7 jobs found in San Diego

CMC Project Manager Job #19-03A   Mapp Biopharmaceutical, Inc. "Mapp" is an innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases. The CMC Project Manager is responsible for facilitation of the technical Drug Substance and Drug Product scope which includes, but is not limited to, process and method development, manufacturing, packaging/labeling, storage and inventory management.  The CMC Project Manager is directly responsible for management of scope, schedule, budget, risk, contractual reporting deliverables, and providing CMC vendor oversight. This person will also be a CMC conduit into the non-clinical and clinical teams.  Ability to travel internationally (India, specifically) is critical and some domestic travel will also be required. The ability to effectively work within a virtual team is critical.    Basic Qualifications: BS or equivalent in Science required Minimum of 5 years in a technical Drug Development/Commercialization CMC role, such as, analytical, process, quality Minimum of 5 years in a Project Management role overseeing CMC-related effort within a Drug Development or related organization Previous experience with large molecule programs such as monoclonal antibodies Practical experience as a scientist in a CMC discipline (Drug Substance, Drug Product, Analytical, Quality, Regulatory etc.) within a Drug Development, CMO or closely related field Experience as a Project Manager responsible for CMC scope of work, such as Drug Substance or Drug Product Development and Manufacturing Practical experience with Large Molecule development, notably with monoclonal antibodies Understanding of the Drug Development paradigm from Candidate Selection through Commercialization Understanding of how all the CMC functions fit together to form the integrated CMC plan and on how CMC fits into the overall Product Development strategy (Clinical & Non-clinical) Experience in leading a team through planning with an integrated schedule in Microsoft Project as the output Experience in representing CMC scope of work and providing CMC updates to the overall program team Experience tracking project progression both in terms of timeline and budget Experience in leading a team through risk, mitigation, contingency and impact assessments Ability to provide effective project communications, verbal and written, tailored for specific audiences Demonstrated organizational skills, strong verbal and written communication skills, and attention to detail Ability to work independently (with minimal supervision) as well as work in a team environment with changing timelines and priorities Willingness and ability to travel internationally 4-6 times per year Preferred Qualifications: MS Degree is an asset PMP Certificate is an asset Experience with US government contracting and Project Management deliverables an asset Previous experience establishing effective working relationships in a virtual environment is an asset Responsibilities Responsible for all Project Management deliverables related to CMC scope of work for a specific program, including scope, schedule, budget, risk management, and government reporting deliverables Partners closely with the Program Manager, Principal Investigator and the other functional PMs to assure all CMC program deliverables are rolling up to the integrated program and program deliverables are being met Leverages the PM tools, templates and guidances to track adherence to the CMC scope of work, schedule and budget and provide diligent management of the PM change control processes Facilitates issue identification/resolution/monitoring and scenario planning as necessary Flags potential issues and constraints early, conducts impact analysis, work with team to provide mitigation strategies and aids in crafting of stakeholder communications as necessary Understands overall program risk register, regularly reviews CMC risks with the team, tracks and evaluates potential CMC risk triggers, conducts impact analysis, helps define mitigation and contingency strategies, and aids in crafting stakeholder communications as necessary Manages all vendor (CMO) relationships as the Mapp operational Point of Contact (POC) required to enable the execution of the CMC scope, including but not limited to, Drug Substance development and manufacturing site, Drug Product development and manufacturing site, analytical test site(s), clinical packaging and labelling, and storage, through frequent telecons, webcons and on-site visits as required Acts as POC responsible for the vendors to assure all Project Management deliverables are being met by the vendor including scope management, schedule, budget, reporting and contractual requirements Partners with CMC technical leads to facilitate the planning and execution of CMC scope including all aspects of development of the processes, manufacturing, analytical control strategies, packaging and labeling, and storage through the lifecycle of the program Partners closely with the Non-clinical and Clinical teams to assure the suitable material availability and inventory for Non-clinical and Clinical study needs Oversees the storage of all CMC samples, final bulk Drug Substance and Drug Product Collaborates with Quality Assurance and Clinical Operations to manage and monitor material inventories Coordinates the CMC information from the Mapp technical team to meet the Program contractual deliverables including monthly reports, regular updates etc. Facilitates internal CMC team meeting, providing agendas, pre-reads, meeting minutes and action items Partners with the CMC technical leads on CMC project progress updates and communications to the Program team and External Stakeholders Works with the Mapp Project Management organization to help establish and maintain tools, templates and processes for management of scope, schedule, budget, risk and reporting Interacts, networks and communicates effectively through telecons, webcons and e-mails with Mapp virtual development team Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego, CA or may have the opportunity to work remotely. Domestic travel will be approximately 10-15% and International travel (India specifically) will be up to six (6) times per year and will be required for this position. Mapp wants you to join their team and invites you to apply. No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify. Mapp is an Equal Opportunity/Affirmative Action/Disability/Vets Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/j/975230-307440

Senior Advisor Clinical Operations Job #19-02A  Part-Time (50%) Mapp Biopharmaceutical, Inc. "Mapp" is an innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases. The Senior Advisor Clinical Operations is responsible for providing deep technical expertise and assisting in the management of contract research organizations (CROs) and clinical development across programs at Mapp Biopharmaceutical. Basic Qualifications: Masters degree or equivalent with 20-years minimum of relevant experience in Clinical Operations Experience in management, oversight, and execution of clinical trials conducted within and outside of the United States Experience in selection and management of CROs both within the United States and in Africa Previous experience conducting clinical trials and managing clinical sites and CROs in developing countries and in resource limited environments Experience making investigational drugs available to patients under FDA's expanded access regulations and other compassionate use provisions outside of the United States Experience interacting with ethical and regulatory authorities in central or western Africa or in equivalent countries with a similar setting Previous experience developing investigational products for the treatment or prevention of rare diseases Experience developing investigational products for the treatment or prevention of diseases in the context of ongoing epidemic(s) Experience with FDA Animal Rule requirements for licensing drugs Demonstrated ability to work remotely with domestic and international team and in the context of ongoing outbreaks or epidemics teams Willing and capable to assist with multiple projects and responsibilities Experience in management of clinical studies in the United States and Africa Ability to engage in domestic travel and international travel to the degree appropriate to support in-country operations and business of the team Understanding of FDA, GCP, ICH and/or other regulatory requirements that may impact global clinical studies and clinical trial management Detail oriented with proven organization, prioritization and collaboration skills Ability to work independently in a virtual team environment as well as within multi-disciplinary project teams Experience supporting government contracts Outstanding written/verbal communication and presentation skills Preferred Qualifications: Ability to manage multiple projects in a dynamic team environment which requires creativity, innovation and thinking outside the box Ability to influence colleagues and leaders in various departments Customer focused, passion to succeed and promote team work with high integrity Responsibilities Provides guidance in all aspects of conducting IND studies (Phase I-IV and expanded access), with emphasis on study design, planning and management Provides input and guidance on the selection, management and oversight of CRO and other vendors both within and outside the United States Assists the Mapp clinical operations team in providing technical leadership to its CROs through effective coaching and development Manages and assists in training team members in Africa for their roles to ensure compliance with study requirements, GCP and ICH Guidelines, and applicable local regulations Provides technical input and expertise to cross-functional project teams, prepares written and oral presentations, authors or reviews protocols, procedures, clinical study reports and collaborates/interacts with cross functional groups including Clinical Operations, Project Management, Regulatory and Quality Provides guidance and instruction to key clinical research personnel within Mapp and its subcontractors on current operating procedures, work instructions and project scope Assists with tracking and oversight of activities related to project progress, budget, timeline and resource allocation Participates in the development and implementation of process improvement initiatives Manages vendor, consultant and subcontractor activities both in the United States and Africa Provides technical input into the clinical operations group for deliverables from the development phase to regulatory filing for commercialization Provides mentorship, advice and guidance to Mapp clinical team members Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego, CA or may have the opportunity to work remotely. Domestic travel of approximately four times per year and international travel of less than two times per year will be required for this position. Mapp wants you to join their team and invites you to apply. No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify. Mapp is an Equal Opportunity/Affirmative Action/Disability/Vets Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/j/973203-307440

Senior Director of Regulatory Affairs Job #19-01R     Mapp Biopharmaceutical, Inc. "Mapp" is an innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat  a variety of neglected and tropical infectious diseases. The Senior Director of Regulatory Affairs will be responsible for developing and leading CMC regulatory strategies and activities for the organization, including the CMC sections of regulatory submissions. This position will serve as a key member of the CMC leadership team and the regulatory team, and may provide regulatory support for other disciplines as needed. Basic Qualifications: PhD (or equivalent) with 5 years prior experience in a technical role in the CMC function, as an analytical lead or downstream process (DSP) or upstream process (USP) lead for a mAb, or MS (or equivalent) with 7-10 years in a technical role in the CMC function as an analytical lead or DSP or USP lead for a mAb, or BS with 10- 15 years in a technical role in the CMC function, as an analytical lead or DSP or USP lead for a mAb 7-10 years of experience in regulatory affairs in pharmaceutical/biotech industry with a focus on CMC activities and CMC Regulatory Affairs 5+ years of demonstrated success in regulatory team leadership role and proven management by influence Prior monoclonal antibodies or protein therapeutics BLA filing experience Direct experience with FDA Demonstrated experience managing complex virtual and matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization Demonstrated experience in developing effective and successful regulatory strategies for the CMC organization Direct experience in leading a mAb/protein therapeutic through the drug development process through BLA submission, approval, and launch of the product Must have direct experience in written and verbal interactions and negotiations with FDA related to CMC issues/submissions Experience in establishing portfolio and program CMC Regulatory strategy from pre-Candidate Selection through Post-Licensure Thorough drug development technical expertise in all aspects of CMC Experience in commercialization of monoclonal antibody therapies Ability to interpret, communicate, and present regulatory information in a clear, concise and timely manner Ability to provide effective project communications, verbal and written, tailored for specific audiences Ability to translate complex information into a logical and credible plan Ability to work independently (with minimal supervision) as well as work in a team environment with changing timelines and priorities Demonstrated organizational skills and attention to detail Familiarity with eCTD requirements and e-submission formats/processes Preferred Qualifications: Advanced degree or equivalent in a related field Experience in interacting and negotiating with non-US Regulatory Agencies Experience with post-approval change management, comparability assessment, post-marketing commitments and overall product life cycle management Experience with FDA Animal Rule requirements for licensing drugs Experience with US government acquisition and procurement contracting and Project Management deliverables Experience in supporting US Government grant or proposal planning and writing Previous experience in labor and capacity planning Previous experience establishing effective working relationships in a virtual environment Previous experience with mentoring and/or development of employees Previous experience developing drugs for rare diseases/Orphan drugs Previous experience with FDA's regulations on expanded access to investigational drugs Previous experience working with regulatory authorities in developing countries and in resource limited environments Previous experience developing good working relationships with regulators at all levels of the FDA especially in CMC related areas Ability to effectively work remote/virtual (if applicable) using telecons and web conferences to both interact with product development teams, direct reports, and senior management Responsibilities Ensures that all CMC regulatory goals are met and are in compliance with current industry standards and global regulations, and are effectively networked with government funding stakeholders. Serves as the global steward of CMC Regulatory Affairs processes, procedures, and tools to facilitate effective execution of the regulatory function across the CMC organization Participates in the development of regulatory strategies for the company as well as for product development teams Acts as a key member of the product development, CMC and regulatory leadership teams at Mapp Serves as the CMC regulatory representative to drug substance/product development teams and provide input to key development decision and documents Ensures that all CMC regulatory goals are met and are in compliance with current industry standards and global regulations, and are effectively networked with government funding stakeholders. Serves as the global steward of CMC Regulatory Affairs processes, procedures, and tools to facilitate effective execution of the regulatory function across the CMC organization Participates in the development of regulatory strategies for the company as well as for product development teams Acts as a key member of the product development, CMC and regulatory leadership teams at Mapp Serves as the CMC regulatory representative to drug substance/product development teams and provide input to key development decision and documents May act as the primary point of contact with Health Authorities on CMC matters. Facilitates CMC interactions, presentations and negotiations and is responsible for the oversight of CMC interactions with Health Authorities. Develops effective working relationships with the regulators at the leadership level and not just the transactional level Interprets and communicates FDA (and other regulatory body) messages pertaining to CMC matters, expectations and decisions to internal and external stakeholders (including CRO's, CMO's, consultants and contractors) on a timely basis Advises senior management on the impact the changing regulatory environment can/will have on Mapp business and project Participates in portfolio and program-level strategy establishment, decision-making, issue resolution, communications strategy, and resourcing/capacity evaluations as the CMC Regulatory Affairs representation Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego, CA or may have the opportunity to work remotely.  Travel (~20%) will be required for this position.  Mapp wants you to join their team and invites you to apply. No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify. Mapp is an Equal Opportunity/Affirmative Action/Disability/Vets Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/j/971562-307440

Please use Google Chrome or Mozilla Firefox when accessing Candidate Home. By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spirit at its best. Are you ready to be part of the world's largest humanitarian network? Job Description: Phlebotomist/Mobile Driver Job Summary Are you seeking a full-time opportunity that makes a difference? Are you passionate about meeting new people? Do you want to have an impact in your community, across the country, and around the world? If your answer is “yes”, then we invite you to become a Phlebotomist/Mobile Driver for the American Red Cross! From transporting and setting up blood collection equipment at work sites, to drawing blood from donors, as a Phlebotomist/Mobile Driver with the American Red Cross you will work all aspects of blood drives at schools, offices & churches throughout PHX and the surrounding areas. No experience necessary —our paid training is a mix of classroom instruction and field practice. To learn more about this role, watch this short video: A life-saving mission. A life-changing career. Join us. Phlebotomist/Mobile Driver Job Responsibilities Balance production, donor care & quality requirements to meet daily blood collection goals Take the time to personally connect with donors – listen to their stories and help them understand the value of their donation Be detail oriented all day, every day, to ensure that the blood you collect meets regulatory requirements and can be safely transfused Remain flexible to work a highly variable schedule that includes early start times, late end times, weekends & holidays to meet the needs of our blood drive sponsors and donors. Take care of your team members – show up for every shift and give 100% while you’re there Contribute to a friendly and fun environment. Team up with your co-workers to keep our donors coming back again and again Interact in a positive, proactive and customer-focused manner with both internal and external customers, demonstrating care and compassion at all times The aforementioned responsibilities of the Phlebotomist/Mobile Driver describe the general nature and level of work and are not an exhaustive list. Phlebotomist/Mobile Driver Job Qualifications High school diploma or equivalent required Customer service experience, effective verbal communication, and public relations skills are required Experience driving large vehicles strongly preferred Ability to load, drive and unload vehicles with or without reasonable accommodation Medical assistant or phlebotomy training preferred but not required A current, valid driver's license and good driving record is required Basic computer skills are desirable DOT certification may be required in some locations. If required, must pass applicable DOT physical and related requirements and be able to possess or obtain a medical certification of at least one year duration Physical requirements may include the ability to lift up to 50 lbs., occasionally physically assisting donors experiencing an adverse reaction, as well as pushing or pulling heavy weights up and down ramps and stairs (potentially up to 250 lbs in weight and with up to 75 degree angles ). Physical requirements may be performed in adverse weather conditions. All staff work as a team to setup and tear down the equipment required to conduct a mobile blood drive. This involves loading/unloading of vehicles, pushing carts up to 250 lbs , setting up beds and handling many totes containing equipment and snacks for the donors. Flexibility to work long, irregular hours and frequent schedule changes is required Apply now! Joining our team will provide you with the opportunity to make a difference every day. The American Red Cross is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. ​ The American Red Cross is a diverse nonprofit organization offering its employee’s professional development and growth opportunities, a competitive salary, comprehensive benefits, and a collaborative team spirit environment. To be considered for this position, please visit www.redcross.org/jobs to apply. To view the EEOC Summary of Rights, click here: Summary of Rights

Please use Google Chrome or Mozilla Firefox when accessing Candidate Home. By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spirit at its best. Are you ready to be part of the world's largest humanitarian network? Job Description: Manages and administers the delivery of American Red Cross services to meet the needs of United States military members, veterans, and their families in accordance with Red Cross policies and procedures. This is accomplished through managing volunteers and working with other Red Cross departments. Responsibilities: 1. Relationship Management and Community Outreach: Builds strong relationships with military leadership, key organizations and community leaders. Cultivates relationships and partnerships with external constituents in the local community, including government organizations, corporate partners, civic organizations and other community charitable and nonprofit agencies with the purpose of furthering the mission of the Red Cross. Outreach includes command meetings, education briefings, presentations or information sessions. 2. Volunteer Management: Manages a volunteer program to enable delivery of SAF programs and services. Provides supervision of both paid and volunteer staff. Helps ensure volunteer staff ratio reflects the diversity of the population being served. 3. Service Delivery Management: Ensures the consistent delivery of the SAF core services to all clients in their area. • Coordinates services to military treatment facilities and VA hospitals through rehabilitation programs, material assistance, and morale items and support. • Ensures community outreach, to include command meetings and education briefings, presentations, or workshops. • Ensures a strong military community outreach program and implementation of special events and projects in support of SAF initiatives. • Manages support services to military members and their families to include family follow-up information and referrals; and other related services. Provides support for the emergency communications center with local information, as appropriate. • Ensures military and veteran community is offered resiliency training. 4. Financial and Reporting Management: Manages expenditures to ensure programs are operating within budget to support SAF programs and services. Monitors and reports on the outcomes and results of programs and services to ensure organizational accountability and makes recommendations for continuous improvement to ensure metrics are consistently met. CONUS (United States and territories): • Works closely with Regional Volunteer Manager to develop and implement a regional SAF volunteer program. • Partners with the Regional communication team to support strong visibility for SAF in the community. • May oversee International Services. OCONUS (overseas military locations): • Develops and implements a strategic volunteer engagement plan. • Provides supervision of both paid and volunteer staff and management of all related human resources functions including recruitment, training, utilization, evaluation and recognition in accordance with Red Cross policies and procedures. • Manages financial and administrative functions in accordance with policies and procedures of American Red Cross. • Manages the delivery of Preparedness, Health and Safety Services training, disaster preparedness and response, resiliency programs with Red Cross support to the Armed Forces Blood Services. The above statements are intended to describe the general nature and level of work being performed. They are not intended to be an exhaustive list of all responsibilities and duties required. Essential Functions/Physical Requirements: Depending on work assignment, may require ordinary ambulatory skills sufficient to visit other locations; or the ability to stand, walk and manipulate (lift, carry, move) light to medium weights of up to 20 pounds. Requires good hand-eye coordination, arm, hand and finger dexterity, including ability to grasp, and visual acuity to use a keyboard, operate equipment and read technical information. Overall mobility is essential. May include sitting for long periods of time, driving a vehicle and working under challenging conditions. Work Conditions: Work is performed indoors with some potential for exposure to safety and health hazards related to emergency services relief work. May travel and participate in meetings and conferences throughout chapter jurisdiction, state and Red Cross system. Because the Red Cross is a disaster response organization, staff may be asked to be on 24-hour call during period of major disaster. Qualifications: Education: Bachelor’s degree in business or public administration, human resources management, community organization, social or health sciences, or related field is required; or related equivalent experience. Experience: A minimum of five years related experience in program management or related field is required. Managerial Experience: A minimum of 1 year of successful supervisory experience is required. Skills and Abilities: Requires strong computer skills. Public speaking skills and the ability to communicate effectively verbally and in writing are required. Must have strong interpersonal skills and the ability to work well in an individual or team environment. The ability to balance multiple priorities is essential. Familiarity with military culture, regulations and protocol is strongly desired. Experience with American Red Cross programs and services are desired. For Mobile positions: • U.S. citizenship is required. Must be able to obtain a secret security clearance and a no-fee U.S. passport. • Worldwide mobility is a condition of employment and an essential function of this position. Must accept work assignments anywhere in the world, including conflict areas, where the American Red Cross is providing services to members of the military and their families. • Must meet strict medical and physical requirements, including immunizations required by the U.S. military. • May be required to wear military uniforms, and live and work in harsh and stressful environment in conflict areas. • Periodically accompanies the military on deployments. Apply now! Joining our team will provide you with the opportunity to make a difference every day. The American Red Cross is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. ​ The American Red Cross is a diverse nonprofit organization offering its employee’s professional development and growth opportunities, a competitive salary, comprehensive benefits, and a collaborative team spirit environment. To be considered for this position, please visit www.redcross.org/jobs to apply. To view the EEOC Summary of Rights, click here: Summary of Rights

Please use Google Chrome or Mozilla Firefox when accessing Candidate Home. By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spirit at its best. Are you ready to be part of the world's largest humanitarian network? Job Description: Are you seeking an opportunity that makes a difference? Are you passionate about meeting new people? Do you want your talents to have an impact in your community, across the country, and around the world? If your answer is “yes,” then we invite you to become a Registered Nurse (RN or LPN) for the American Red Cross! Nationwide, we collect over 5 million units of blood annually, and the need continues to grow. From leading our blood collection team, to going above and beyond to ensure that all donors have an optimum donor experience, as a Registered Nurse (RN or LPN) you will lead a team, draw blood and may be required to supervise blood drives. To learn more about the life-saving impact our employees have every day, watch this short video: A lifesaving mission. A life-changing career. Join us . Registered Nurse (RN or LPN) Job Responsibilities Conduct phlebotomy and charge at blood drives. Work independently with attention to detail and possess the necessary knowledge of all aspects of daily operations. Be detail oriented all day, every day, to ensure that the blood you collect meets regulatory requirements and can be safely transfused. Remain flexible to work a highly variable schedule that includes early start times, late end times, weekends and holidays to meet the needs of our blood drive sponsors and donors. Drive for results and to serve others with a high level of respect for customer service. Contribute to a friendly and fun environment. Team up with your co-workers to keep our donors coming back again and again. Take care of your team members – show up for every shift and give 100% while you’re there. Be a model of professionalism and compassion while serving as an ambassador to the public for the nation’s largest not-for-profit blood banking organization. The aforementioned responsibilities of the Registered Nurse (RN) describe the general nature and level of work and are not an exhaustive list. Registered Nurse (RN/LPN) Job Qualifications Registered Nurse license required (RN/LPN) Previous customer service experience and strong work ethics Customer service experience, effective verbal communication and public relations skills are preferred. A current valid driver’s license and good driving record are required. Physical requirements may include the ability to lift up to 50 lbs., occasionally physically assisting donors experiencing an adverse reaction, as well as pushing or pulling heavy weights up and down ramps and stairs (potentially up to 250 lbs in weight and with up to 75 degree angles ). Physical requirements may be performed in adverse weather conditions. All staff work as a team to setup and tear down the equipment required to conduct a mobile blood drive. This involves loading/unloading of vehicles, pushing carts up to 250 lbs , setting up beds and handling many totes containing equipment and snacks for the donors. Flexibility to work long, irregular hours and frequent schedule changes is required Apply now! Joining our team will provide you with the opportunity to make a difference every day. The American Red Cross is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. ​ The American Red Cross is a diverse nonprofit organization offering its employee’s professional development and growth opportunities, a competitive salary, comprehensive benefits, and a collaborative team spirit environment. To be considered for this position, please visit www.redcross.org/jobs to apply. To view the EEOC Summary of Rights, click here: Summary of Rights

Senior Advisor Job #12-17A   Mapp Biopharmaceutical is a small biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of diseases, such as neglected and tropical infectious diseases. The Senior Advisor is responsible for leading and managing multi-expression platform process development and contract manufacturing organization (CMO) activities in the Mapp Biopharmaceutical Biologics Bulk Drug Substance area. The BioProcessing Senior Advisor will support the design, development, characterization and validation of Drug Substance manufacturing and control processes for the Mapp Biopharmaceutical monoclonal antibody programs pre-Candidate Selection through to Commercialization.  This person will work closely with a cross-functional virtual team and CMOs.  Responsibilities include the development and optimization of downstream purification processes, including scale-up/Tech Transfer to GMP manufacturing. The successful candidate is expected to work independently on assigned tasks/projects and to prioritize assignments to meet timeline targets.   Basic Qualifications: D. in a relevant discipline such as Chemical Engineering, Biomedical Engineering, Biochemistry, Molecular Biology, or related discipline Minimally 15 years experience or M.S. and 20 years equivalent and years of relevant industrial experience in DSP process development and internal or external GMP manufacturing and process validation of therapeutic biologics drug substance including recombinant protein, fragment antibody, monoclonal antibodies Minimum 15+ years (for BS) or 10+ years (for MS) experience in biomolecule downstream process development and/or GMP manufacturing Familiar with laboratory to large-scale chromatography equipment and Tangential Flow Filtration (TFF) operations Experience with analytical methods used for downstream process development Experience with Upstream activities is an asset Experience leading a group of scientists and engineers with diverse technical and educational levels, manage development activities for plant or mammalian production and be accountable for timelines, progress and deliverables from the development phase to regulatory filing for commercialization Experience leading platform expression systems that could include plant, microbial or mammalian-derived downstream purification process development and optimization, scale up, technology transfer, process validation, process mapping and characterization and manufacturing activities at small scale at internal or CMO laboratory and Phase 1-3 clinical scale or commercial scale at 1st Party, 2nd Party or 3rd Party/CMO sites Established track record of sustained performance and deliverables for development and GMP manufacturing of plant or mammalian processes at internal or external clinical/commercial manufacturing sites in a small, mid to large Pharmaceutical / Biotechnology industry Experience having executed tech transfer and GMP production for Phase 1-3 clinical and/or commercial manufacturing at CMOs for mammalian-derived biotechnology derived drug substance Experience in process development and GMP manufacturing of recombinant proteins, FAb, and mAb Experience in Process Modeling, COGs analysis, Process Improvement Lean Six Sigma, Production Planning/Scheduling and demonstrated use of DOE, QbD and FMEA are a plus In-depth knowledge and hands-on biotechnology industry experience in development and manufacturing and process validation of plant or mammalian processes Knowledge of the applicable global regulations, cGMP, ICH, and Quality Systems including Change Control, Investigations, and Deviations Strong leadership, prioritization, quick decision-making, people management skills Ability to work independently as well as within multi-disciplinary project teams Outstanding written/verbal communication and presentation skills are essential Ability to manage multiple projects in a dynamic team environment which require creativity, innovation and thinking outside the box Detail oriented with proven organization, prioritization and collaboration skills Ability to cultivate excellent cross-functional collaborations, effectively communicate at multiple levels of the organization Ability to influence colleagues and leaders in various departments Customer focused, passion to succeed and promote team work with high integrity Knowledge of downstream process development for biologicals, including but not limited to product recovery, purification, and formulation development Experience with downstream process development, at both the bench and pilot scales, using a wide range of purification techniques (including recovery, clarification, and chromatography of all types, precipitation, UF/DF, formulation, etc) and analytical methods (HPLC, SDS-PAGE, IEF, Western blot, assay for Endotoxin (LAL), Host cell proteins evaluation, UV/Vis Spectrophotometry, BCA and Bradford protein concentration assays) Experience in providing on-site technical oversight and troubleshooting during manufacturing operations at pilot and/or commercial scale Experience with technology transfer and process scale-up for clinical and commercial manufacture desired Experience in a cGMP environment Experience with process study protocol development, execution, data analysis and final report completion Experience in the preparation of a process data package for BLA submission is an asset  Task & team-oriented, analytical, organized, detail-oriented, self-motivated & ability to multitask Excellent record keeping abilities to adequately document process development data   Preferred Qualifications: Process/chemical engineering background is desirable   Responsibilities Provides leadership and develops/mentors staff internally or at CMO through effective coaching and development Leads and oversees clinical manufacturing for therapeutic biologics in Development Responsible for plant or mammalian process development, mapping, characterization, scale-up and manufacturing oversight at contract sites, process mapping and characterization from early to late-stage process development and manufacturing up to regulatory submissions and technical support during commercial manufacturing phase Conducts and/or oversees laboratory studies to define downstream purification process parameters for scale up, tech transfer and GMP manufacture of process consistency and Phase 1 to 3 drug substance batches in adherence to technical excellence, corporate goals, project timelines, global regulations and quality compliance Leads the development strategy for plant-based and/or mammalian production Accountable for timelines, progress, and deliverables from the development phase to regulatory filing for commercialization Provides technical input and expertise to cross-functional project teams, prepare written and oral presentations, authors/reviews/approves protocols/reports and collaborates/interacts with internal customers including other functions within Biologics Development as well as Project Management, Research, Legal, Regulatory, Quality, Manufacturing and CMOs Works closely with CMO technical teams to develop scalable downstream processes for product recovery, clarification, purification, and formulation of monoclonal antibody bulk Drug Substance molecules Supports process scale up for cGMP manufacturing; reviews production batch records for GMP manufacturing, supports and troubleshoots cGMP production activities Reviews protocols, procedures, data analyses, and reports for process development, characterization and robustness studies Provides on-site oversight before, during, and after manufacturing operations at the CMO, as needed Provides support for the statistically sound study design and study data analysis Partners closely with analytical chemists, other process chemists, quality, regulatory and project management Reviews CMO study protocols, data, and reports and deviation documentation for scientific soundness and accuracy Authors and reviews internal reports, memos, summary documents, and contributes to regulatory submission documents Performs statistical analysis on process data as necessary using programs such as JMP (or equivalent) Participates in the establishment of process control strategies Ensures proper documentation and reporting of experiments and results Other duties as assigned   Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego, CA or may have the opportunitiy to work remotely. Mapp wants you to join their team and invites you to apply.   No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.   Equal Opportunity Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. https://www.applicantpro.com/j/671986-186114