Mapp Biopharmaceutical, Inc.
4921 Directors Place #100, San Diego, California
Office Administrator
Temporary Assignment Through Agency - Potential Future Option for Regular Employee
9:00AM - 2:00PM On-Site
Job #24-03RT / #24-03R
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, 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, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory, Project Management, and Clinical activities consistent with Mapp's product development objectives.
The Office Administrator will be an on-site support employee that assists various departments in performance of administrative activities for both on-site and virtual employees.
Basic Qualifications
2 years' experience acquired through relevant administrative support experience
Excellent skills in MS Office applications and internet skills required
Excellent Outlook calendaring skills required
Excellent skills in setting up teleconferences while utilizing various programs (Zoom, Teams) required
Acts with a professional demeanor at all times
Ability to work with all levels of management and handle confidential information
Service oriented and helpful demeanor
Effective organizational skills, attention to detail
Effective problem-solving skills and results oriented
Ability to write clear, concise e-mails
Excellent writing, spelling, grammar and interpersonal communication skills in English
Excellent telephone and oral communication skills
Ability to work in a fast-paced environment and multi-task efficiently
Ability to apply common sense and critical thinking to carry out instructions and make decisions within scope of authority
Ability to deal with problems involving several variables
Ability to streamline processes
Ability to manage and juggle projects, both short and long term, to fruition
Preferred Qualifications
AA Degree or equivalent preferred
Fluency in Spanish preferred but not required
Responsibilities
Greets visitors and notifies employees of visitor's arrival in the lobby
Ensures visitor log is completed accurately and any visitor documents are signed and retained
Acts as on-site contact to assist in ensuring smooth business operations
Sets up iPads and other needs in conference rooms
Answers main phone line and directs messages to employees
Orders office supplies for Mapp employees upon request and ensures office supply inventory is adequately maintained on frequently utilized items
Distributes incoming mail; scans and emails incoming mail to recipient upon request
Submits receipts on a weekly basis for expense reports in a timely manner
Sets up Zoom meetings and reserves conference rooms as needed
Coordinates and schedules on-site meetings as needed
Provides basic administrative support as needed
Works synergistically with the Facility Operations Administrator and the Administrative/Legal Administrator and acts as back-up if requested or needed
Coordinates San Diego office luncheons (catering, food trucks) as needed
Coordinates hotel arrangements and may coordinate other travel for employees as needed
Coordinates travel arrangements for visitors to the Mapp facility as needed
Mapp's anticipated pay scale for this temporary position through an agency is $26.44 to $26.45. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the candidate's level of education, and type and length of experience within the job and/or within the industry.
Mapp's anticipated pay scale for any potential future regular position is $26.44 to $26.45, plus any applicable bonuses. Medical, dental, and vision insurance benefits are available to eligible employees and their families. Mapp also provides basic life insurance, short and long term disability, and a 401K plan that includes Company contributions to eligible employees. Full time employees will be provided 7 days of sick time, 14 paid holidays, and will also accrue 18 days of vacation throughout the calendar year.
This position is an on-site position located in Mapp's new state-of-the-art San Diego facility. Mapp may elect to post and fill this position as a regular employee in the future.
Mapp invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/ . This job will remain open for twenty (20) days after being posted on Mapp's Job Openings website page (see link).
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified 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.
Office Administrator
Temporary Assignment Through Agency - Potential Future Option for Regular Employee
9:00AM - 2:00PM On-Site
Job #24-03RT / #24-03R
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, 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, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory, Project Management, and Clinical activities consistent with Mapp's product development objectives.
The Office Administrator will be an on-site support employee that assists various departments in performance of administrative activities for both on-site and virtual employees.
Basic Qualifications
2 years' experience acquired through relevant administrative support experience
Excellent skills in MS Office applications and internet skills required
Excellent Outlook calendaring skills required
Excellent skills in setting up teleconferences while utilizing various programs (Zoom, Teams) required
Acts with a professional demeanor at all times
Ability to work with all levels of management and handle confidential information
Service oriented and helpful demeanor
Effective organizational skills, attention to detail
Effective problem-solving skills and results oriented
Ability to write clear, concise e-mails
Excellent writing, spelling, grammar and interpersonal communication skills in English
Excellent telephone and oral communication skills
Ability to work in a fast-paced environment and multi-task efficiently
Ability to apply common sense and critical thinking to carry out instructions and make decisions within scope of authority
Ability to deal with problems involving several variables
Ability to streamline processes
Ability to manage and juggle projects, both short and long term, to fruition
Preferred Qualifications
AA Degree or equivalent preferred
Fluency in Spanish preferred but not required
Responsibilities
Greets visitors and notifies employees of visitor's arrival in the lobby
Ensures visitor log is completed accurately and any visitor documents are signed and retained
Acts as on-site contact to assist in ensuring smooth business operations
Sets up iPads and other needs in conference rooms
Answers main phone line and directs messages to employees
Orders office supplies for Mapp employees upon request and ensures office supply inventory is adequately maintained on frequently utilized items
Distributes incoming mail; scans and emails incoming mail to recipient upon request
Submits receipts on a weekly basis for expense reports in a timely manner
Sets up Zoom meetings and reserves conference rooms as needed
Coordinates and schedules on-site meetings as needed
Provides basic administrative support as needed
Works synergistically with the Facility Operations Administrator and the Administrative/Legal Administrator and acts as back-up if requested or needed
Coordinates San Diego office luncheons (catering, food trucks) as needed
Coordinates hotel arrangements and may coordinate other travel for employees as needed
Coordinates travel arrangements for visitors to the Mapp facility as needed
Mapp's anticipated pay scale for this temporary position through an agency is $26.44 to $26.45. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the candidate's level of education, and type and length of experience within the job and/or within the industry.
Mapp's anticipated pay scale for any potential future regular position is $26.44 to $26.45, plus any applicable bonuses. Medical, dental, and vision insurance benefits are available to eligible employees and their families. Mapp also provides basic life insurance, short and long term disability, and a 401K plan that includes Company contributions to eligible employees. Full time employees will be provided 7 days of sick time, 14 paid holidays, and will also accrue 18 days of vacation throughout the calendar year.
This position is an on-site position located in Mapp's new state-of-the-art San Diego facility. Mapp may elect to post and fill this position as a regular employee in the future.
Mapp invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/ . This job will remain open for twenty (20) days after being posted on Mapp's Job Openings website page (see link).
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified 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.
Choate, Hall & Stewart LLP
Boston, MA
Choate is seeking a highly motivated and detail-orientated Governance, Risk, and Compliance (GRC) Analyst to join the Information Security team. The GRC Analyst will be responsible for supporting the development, implementation, and maintenance of the firm’s governance, risk management, and compliance program. The ideal candidate will have a strong understanding of regulatory requirements, risk management frameworks, and information security. They will have experience performing third-party risk assessments and will be familiar with the ISO 27001 certification.
Job Functions:
Assist with continued development and enhancements to the firm’s governance, risk management and compliance program.
Support the firm’s client’s by responding to information security assessments.
Perform information security risk assessments on the firm’s third-party vendors and suppliers.
Collaborate with the Information Security Director and other stakeholders to improve security procedures, training, IT processes, and the security of existing systems.
Review and update the firm’s information security policies.
Track and schedule activities related to certifying the firm’s Information Security Management System’s ISO27001 certification.
Coordinate with other IT teams and other departments to perform risk assessments and track risk mitigation and remediation.
Effectively communicates with stakeholders at all levels of the organization.
Analyzes and reports on risk trends and metrics.
Analyze client and stakeholder requirements in support of Business Continuity planning efforts.
Support development of Business Continuity and Disaster Recovery plans and related documents in accordance with recognized standards and best practices.
Ideal Qualifications:
Bachelor’s degree or equivalent experience in Information Systems Security or related field.
3+ years of relevant experience working in a related role.
Certifications in relevant areas.
Strong writing / documentation skills.
Highly organized.
Strong communication skills.
Self-starter with the ability to work independently, while having good judgment as to when consultation is required.
Ability to work on multiple projects and perform well under deadlines.
Enthusiastic, flexible, willing to pitch in where needed.
Strong drive to learn and grow in the cyber security field.
Physical Requirements:
Must have minimal physical mobility. Position may occasionally require standing, walking, reaching, and lifting up to 15 pounds.
Must have the ability to operate equipment such as a computer and copy machine.
Must have the ability to communicate clearly and to read and follow detailed instructions.
Must have the ability to prepare assorted documents and other related materials.
Must have the ability to work in stressful conditions under time deadlines.
Choate is seeking a highly motivated and detail-orientated Governance, Risk, and Compliance (GRC) Analyst to join the Information Security team. The GRC Analyst will be responsible for supporting the development, implementation, and maintenance of the firm’s governance, risk management, and compliance program. The ideal candidate will have a strong understanding of regulatory requirements, risk management frameworks, and information security. They will have experience performing third-party risk assessments and will be familiar with the ISO 27001 certification.
Job Functions:
Assist with continued development and enhancements to the firm’s governance, risk management and compliance program.
Support the firm’s client’s by responding to information security assessments.
Perform information security risk assessments on the firm’s third-party vendors and suppliers.
Collaborate with the Information Security Director and other stakeholders to improve security procedures, training, IT processes, and the security of existing systems.
Review and update the firm’s information security policies.
Track and schedule activities related to certifying the firm’s Information Security Management System’s ISO27001 certification.
Coordinate with other IT teams and other departments to perform risk assessments and track risk mitigation and remediation.
Effectively communicates with stakeholders at all levels of the organization.
Analyzes and reports on risk trends and metrics.
Analyze client and stakeholder requirements in support of Business Continuity planning efforts.
Support development of Business Continuity and Disaster Recovery plans and related documents in accordance with recognized standards and best practices.
Ideal Qualifications:
Bachelor’s degree or equivalent experience in Information Systems Security or related field.
3+ years of relevant experience working in a related role.
Certifications in relevant areas.
Strong writing / documentation skills.
Highly organized.
Strong communication skills.
Self-starter with the ability to work independently, while having good judgment as to when consultation is required.
Ability to work on multiple projects and perform well under deadlines.
Enthusiastic, flexible, willing to pitch in where needed.
Strong drive to learn and grow in the cyber security field.
Physical Requirements:
Must have minimal physical mobility. Position may occasionally require standing, walking, reaching, and lifting up to 15 pounds.
Must have the ability to operate equipment such as a computer and copy machine.
Must have the ability to communicate clearly and to read and follow detailed instructions.
Must have the ability to prepare assorted documents and other related materials.
Must have the ability to work in stressful conditions under time deadlines.
Mapp Biopharmaceutical, Inc.
San Diego, CA, USA
Associate Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC)
Job #21-33A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, 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, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio with the CMC, Preclinical/Nonclinical (together, "Nonclinical"), Regulatory and Clinical development goals consistent with the product development objectives of Mapp.
The Associate Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the preparation and filing of regulatory CMC submissions. This position is a hands-on role, providing both strategic and operational activities to support regulatory needs for multiple therapeutics at various stages of development. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads multi-functional technical teams in relation to regulatory expectations. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations. This position reports to the Head of Regulatory Affairs.
Basic Qualifications:
BS or BA Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Biologics, or another life-science related field - Advanced degree is preferred
10 years experience in the biotech industry or in a related field, or the equivalent combination of education and experience, with prior experience in a technical role in the CMC function, for example, as an analytical lead or downstream process (DSP), or upstream process (USP) lead for a mAb development program
2 years of experience in regulatory affairs in pharmaceutical/biotech industry with a focus on CMC activities and CMC Regulatory Affairs with demonstrated success and proven management by influence
Monoclonal antibodies or protein therapeutic IND and/or BLA filing experience
Experience with the FDA in regards to responding to CMC queries and/or requests
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
Experience in leading the CMC activities of a mAb/protein therapeutic through the drug development process through IND and/or BLA submission
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
Drug development technical familiarity in all aspects of CMC for Biologics
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 in commercialization of monoclonal antibody therapies
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 establishing effective working relationships in a virtual environment
Previous experience developing drugs for rare diseases/Orphan drugs and/or antivirals
Previous experience supporting emergency use/expanded access interactions with FDA and other regulatory bodies
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
Drafts regulatory submissions pertaining to CMC development and assists technical team members in compilation of relevant material to support overall product development strategies
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
Acts 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 as needed
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 projects
Participates in portfolio and program-level strategy establishment, decision-making, issue resolution, communications strategy, and resourcing/capacity evaluations as the CMC Regulatory Affairs representative
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will have the opportunity to work in Mapp's new state-of-the-art San Diego facility, or, if your job responsibilities allow, you may choose to work remotely (outside of the State of Colorado.). Willingness to Travel (~<20% = Domestic Travel + ~<10% International Travel) will be required for this position. Mapp wants you to join their team and invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/ .
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified 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/2071703-307440
Associate Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC)
Job #21-33A
Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, 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, and in support of biodefense programs.
The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio with the CMC, Preclinical/Nonclinical (together, "Nonclinical"), Regulatory and Clinical development goals consistent with the product development objectives of Mapp.
The Associate Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the preparation and filing of regulatory CMC submissions. This position is a hands-on role, providing both strategic and operational activities to support regulatory needs for multiple therapeutics at various stages of development. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads multi-functional technical teams in relation to regulatory expectations. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations. This position reports to the Head of Regulatory Affairs.
Basic Qualifications:
BS or BA Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Biologics, or another life-science related field - Advanced degree is preferred
10 years experience in the biotech industry or in a related field, or the equivalent combination of education and experience, with prior experience in a technical role in the CMC function, for example, as an analytical lead or downstream process (DSP), or upstream process (USP) lead for a mAb development program
2 years of experience in regulatory affairs in pharmaceutical/biotech industry with a focus on CMC activities and CMC Regulatory Affairs with demonstrated success and proven management by influence
Monoclonal antibodies or protein therapeutic IND and/or BLA filing experience
Experience with the FDA in regards to responding to CMC queries and/or requests
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
Experience in leading the CMC activities of a mAb/protein therapeutic through the drug development process through IND and/or BLA submission
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
Drug development technical familiarity in all aspects of CMC for Biologics
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 in commercialization of monoclonal antibody therapies
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 establishing effective working relationships in a virtual environment
Previous experience developing drugs for rare diseases/Orphan drugs and/or antivirals
Previous experience supporting emergency use/expanded access interactions with FDA and other regulatory bodies
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
Drafts regulatory submissions pertaining to CMC development and assists technical team members in compilation of relevant material to support overall product development strategies
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
Acts 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 as needed
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 projects
Participates in portfolio and program-level strategy establishment, decision-making, issue resolution, communications strategy, and resourcing/capacity evaluations as the CMC Regulatory Affairs representative
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will have the opportunity to work in Mapp's new state-of-the-art San Diego facility, or, if your job responsibilities allow, you may choose to work remotely (outside of the State of Colorado.). Willingness to Travel (~<20% = Domestic Travel + ~<10% International Travel) will be required for this position. Mapp wants you to join their team and invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/ .
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified 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/2071703-307440