EMILY's List
EMILY’s List, the nation’s largest resource for women in politics, is searching for a Political Advisor to join our Campaigns team. EMILY’s List has raised over $600 million to elect pro-choice Democratic women candidates. With a grassroots community of over five million members, EMILY's List helps Democratic women win competitive campaigns – across the country and up and down the ballot – by recruiting and training candidates, supporting strong campaigns, researching the issues that impact women and families, and turning out women voters to the polls. Since our founding in 1985, we have helped elect 150 women to the House, 26 to the Senate, 16 governors, and nearly 1,100 women to state and local office. Nearly 40 percent of the candidates EMILY’s List has helped elect to Congress have been women of color. During the historic 2017-2018 cycle, EMILY’s List raised a record-breaking $110 million dollars and launched a record independent expenditure campaign. We helped elect 34 new women to the House, including 24 red-to-blue victories; enough seats to have delivered the U.S. House majority alone. Since the 2016 election, more than 40,000 women have reached out to EMILY's List about running for office laying the groundwork for the next decade of candidates for local, state and national offices.
Principal Responsibilities
As a member of the Campaigns Department, the Political Advisor will work to assess the overall campaigns of Pro-Choice Democratic women candidates. The Political Advisor serves as a critical link between EMILY’s List and campaigns on the ground by providing professional advice to the campaign and assessing its operation. The Political Advisor also helps guide campaigns through the course of assessment and endorsement and evaluates the campaign operation continuously throughout the course of the campaign for endorsed candidates.
Specific Duties
Develop and maintain political relationships to identify and recruit strong Pro-Choice Democratic women to run in competitive races;
Work directly with campaigns and advise them on critical components of their operation including:
Building a professional campaign team including recruiting effective campaign managers and other campaign staff;
Developing and maintaining campaign budgets and plans;
Building and executing the campaign strategic plan;
Recommending media consultants, pollsters, mail consultants and other consultants;
Reading polls;
Reviewing and understanding television ad buys;
Establishing high-quality campaign structures for field, research, communications, digital, and fundraising;
Working directly with prospective and endorsed candidates;
Building strong relationships with candidates and campaign staff on behalf of EMILY’s List.
Communicate needs and goals of EMILY’s List endorsement process for candidates;
Understand the needs of individual campaigns and advocate for support from EMILY’s List on their behalf;
Assist with the EMILY’s List training program;
Performs other duties as assigned.
Qualifications
The Political Advisor must be a self-starter with at least six years of campaign and electoral experience, including federal campaign experience. Campaign management experience is highly desired. The Political Advisor must have a strong interest in electing Pro-Choice Democratic Women to office, possess excellent communication skills, good attention to detail, the ability to think on one’s feet, a sense of humor, and a commitment to the diversity of our staff, candidates, members, and partners. The Political Advisor must be willing to travel extensively. Commitment to the diversity of our candidates, membership, partners, and staff required. Commitment and passion to elect Pro-Choice Democratic Women required.
EMILY’s List offers a competitive salary and a strong benefits package. To apply, email resume and cover letter to politicaladvisorjobs@emilyslist.org - subject line including your name and the job title. No calls, please.
EMILY’s List prohibits discrimination of employment, promotion, compensation, terms, conditions, or privileges of employment based on gender, disability, race, age, national origin, color, creed, sexual orientation, sex (including marital and parental status), gender identity and expression, religion, economic status, ethnic identity, veteran's status, or any other basis prohibited by applicable law.
EMILY's List is an Equal Opportunity Employer that values a multi-cultural, diverse working environment. Applicants of diverse backgrounds are welcomed and encouraged to apply.
EMILY’s List, the nation’s largest resource for women in politics, is searching for a Political Advisor to join our Campaigns team. EMILY’s List has raised over $600 million to elect pro-choice Democratic women candidates. With a grassroots community of over five million members, EMILY's List helps Democratic women win competitive campaigns – across the country and up and down the ballot – by recruiting and training candidates, supporting strong campaigns, researching the issues that impact women and families, and turning out women voters to the polls. Since our founding in 1985, we have helped elect 150 women to the House, 26 to the Senate, 16 governors, and nearly 1,100 women to state and local office. Nearly 40 percent of the candidates EMILY’s List has helped elect to Congress have been women of color. During the historic 2017-2018 cycle, EMILY’s List raised a record-breaking $110 million dollars and launched a record independent expenditure campaign. We helped elect 34 new women to the House, including 24 red-to-blue victories; enough seats to have delivered the U.S. House majority alone. Since the 2016 election, more than 40,000 women have reached out to EMILY's List about running for office laying the groundwork for the next decade of candidates for local, state and national offices.
Principal Responsibilities
As a member of the Campaigns Department, the Political Advisor will work to assess the overall campaigns of Pro-Choice Democratic women candidates. The Political Advisor serves as a critical link between EMILY’s List and campaigns on the ground by providing professional advice to the campaign and assessing its operation. The Political Advisor also helps guide campaigns through the course of assessment and endorsement and evaluates the campaign operation continuously throughout the course of the campaign for endorsed candidates.
Specific Duties
Develop and maintain political relationships to identify and recruit strong Pro-Choice Democratic women to run in competitive races;
Work directly with campaigns and advise them on critical components of their operation including:
Building a professional campaign team including recruiting effective campaign managers and other campaign staff;
Developing and maintaining campaign budgets and plans;
Building and executing the campaign strategic plan;
Recommending media consultants, pollsters, mail consultants and other consultants;
Reading polls;
Reviewing and understanding television ad buys;
Establishing high-quality campaign structures for field, research, communications, digital, and fundraising;
Working directly with prospective and endorsed candidates;
Building strong relationships with candidates and campaign staff on behalf of EMILY’s List.
Communicate needs and goals of EMILY’s List endorsement process for candidates;
Understand the needs of individual campaigns and advocate for support from EMILY’s List on their behalf;
Assist with the EMILY’s List training program;
Performs other duties as assigned.
Qualifications
The Political Advisor must be a self-starter with at least six years of campaign and electoral experience, including federal campaign experience. Campaign management experience is highly desired. The Political Advisor must have a strong interest in electing Pro-Choice Democratic Women to office, possess excellent communication skills, good attention to detail, the ability to think on one’s feet, a sense of humor, and a commitment to the diversity of our staff, candidates, members, and partners. The Political Advisor must be willing to travel extensively. Commitment to the diversity of our candidates, membership, partners, and staff required. Commitment and passion to elect Pro-Choice Democratic Women required.
EMILY’s List offers a competitive salary and a strong benefits package. To apply, email resume and cover letter to politicaladvisorjobs@emilyslist.org - subject line including your name and the job title. No calls, please.
EMILY’s List prohibits discrimination of employment, promotion, compensation, terms, conditions, or privileges of employment based on gender, disability, race, age, national origin, color, creed, sexual orientation, sex (including marital and parental status), gender identity and expression, religion, economic status, ethnic identity, veteran's status, or any other basis prohibited by applicable law.
EMILY's List is an Equal Opportunity Employer that values a multi-cultural, diverse working environment. Applicants of diverse backgrounds are welcomed and encouraged to apply.
EMILY's List
Washington, DC, USA
EMILY’s List, the nation’s largest resource for women in politics, is searching for a Deputy Director of Campaign Communications for State and Local to join our Communications team. EMILY’s List has raised over $600 million to elect pro-choice Democratic women candidates. With a grassroots community of over five million members, EMILY's List helps Democratic women win competitive campaigns – across the country and up and down the ballot – by recruiting and training candidates, supporting strong campaigns, researching the issues that impact women and families, and turning out women voters to the polls. Since our founding in 1985, we have helped elect 150 women to the House, 26 to the Senate, 16 governors, and nearly 1,100 women to state and local office. Nearly 40 percent of the candidates EMILY’s List has helped elect to Congress have been women of color. During the historic 2017-2018 cycle, EMILY’s List raised a record-breaking $110 million dollars and launched a record independent expenditure campaign. We helped elect 34 new women to the House, including 24 red-to-blue victories; enough seats to have delivered the U.S. House majority alone. Since the 2016 election, more than 40,000 women have reached out to EMILY's List about running for office laying the groundwork for the next decade of candidates for local, state and national offices.
Principal Responsibilities
The Deputy Director of Campaign Communications for State and Local promotes the mission of EMILY’s List and is an advocate for strong, pro-choice Democratic women candidates and elected officials throughout the country. The Deputy Director of Campaign Communications for State and Local manages the organization’s positioning within the news of the day and capitalizes on creative opportunities for the organization and its down-ballot candidates.
Specific Duties
Work with campaigns and endorsed down-ballot candidates to create effective media and messaging strategies;
Draft and deliver talking points for EL staff and state and local candidates, assist with media training, as needed;
Act as communications hub for breaking news events; help initiate and manage organization’s rapid response on state and local issues;
Collaborate with communications team and organization leadership to craft responses in a timely manner;
Serve as a leader in time-sensitive situations by advising leadership, planning communications strategies, and managing staff and resources to achieve organizational goals;
Craft and maintain communications plan and endorsement calendar to include all organizational press and communications rollouts.
Work with Campaigns Department to help with state and local campaign communications efforts, interact directly with campaigns to provide resources, guidance as needed;
Manage process by which materials are created for the communications department including, but not limited to, briefing materials, press releases, talking points, op-eds, etc.;
Create opportunities showcasing EMILY’s List staff, accomplishments, endorsed candidates, and mission that generates positive press coverage in varied outlets;
Be an aggressive and quick-thinking originator of stories to pitch on behalf of EMILY’s List and our endorsed candidates;
Serve as on-record spokesperson for the organization as needed;
Assist with booking, pitching process within the organization;
Perform other duties as assigned.
Qualifications
Must have experience in communications, working with press;
Experience in a rapid response media environment;
At least one cycle of campaign experience or state legislative press experience is strongly preferred;
Experienced manager of people and processes;
Ability to communicate effectively with diverse audiences and write quickly and in a compelling manner about multiple topics;
Energetic ability to multi-task and manage projects in a fast-paced and changeable environment; willingness to invest multiple teams and stakeholders in communications efforts;
Ability to use multiple mediums and approaches including new media to create multi-faced and effective campaigns;
Ability to work independently and collaboratively;
Commitment to electing pro-choice Democratic women;
Strong, determined team-player with ready sense of humor, thick skin, and a demonstrated willingness to work hard and take risks;
Commitment to the diversity of our candidates, membership, partners, and staff.
EMILY’s List offers a competitive salary and a strong benefits package. To apply, email resume and cover letter to commsjobs@emilyslist.org - subject line including your name and the job title. No calls, please.
EMILY’s List prohibits discrimination of employment, promotion, compensation, terms, conditions, or privileges of employment based on gender, disability, race, age, national origin, color, creed, sexual orientation, sex (including marital and parental status), gender identity and expression, religion, economic status, ethnic identity, veteran's status, or any other basis prohibited by applicable law.
EMILY's List is an Equal Opportunity Employer that values a multi-cultural, diverse working environment. Applicants of diverse backgrounds are welcomed and encouraged to apply.
EMILY’s List, the nation’s largest resource for women in politics, is searching for a Deputy Director of Campaign Communications for State and Local to join our Communications team. EMILY’s List has raised over $600 million to elect pro-choice Democratic women candidates. With a grassroots community of over five million members, EMILY's List helps Democratic women win competitive campaigns – across the country and up and down the ballot – by recruiting and training candidates, supporting strong campaigns, researching the issues that impact women and families, and turning out women voters to the polls. Since our founding in 1985, we have helped elect 150 women to the House, 26 to the Senate, 16 governors, and nearly 1,100 women to state and local office. Nearly 40 percent of the candidates EMILY’s List has helped elect to Congress have been women of color. During the historic 2017-2018 cycle, EMILY’s List raised a record-breaking $110 million dollars and launched a record independent expenditure campaign. We helped elect 34 new women to the House, including 24 red-to-blue victories; enough seats to have delivered the U.S. House majority alone. Since the 2016 election, more than 40,000 women have reached out to EMILY's List about running for office laying the groundwork for the next decade of candidates for local, state and national offices.
Principal Responsibilities
The Deputy Director of Campaign Communications for State and Local promotes the mission of EMILY’s List and is an advocate for strong, pro-choice Democratic women candidates and elected officials throughout the country. The Deputy Director of Campaign Communications for State and Local manages the organization’s positioning within the news of the day and capitalizes on creative opportunities for the organization and its down-ballot candidates.
Specific Duties
Work with campaigns and endorsed down-ballot candidates to create effective media and messaging strategies;
Draft and deliver talking points for EL staff and state and local candidates, assist with media training, as needed;
Act as communications hub for breaking news events; help initiate and manage organization’s rapid response on state and local issues;
Collaborate with communications team and organization leadership to craft responses in a timely manner;
Serve as a leader in time-sensitive situations by advising leadership, planning communications strategies, and managing staff and resources to achieve organizational goals;
Craft and maintain communications plan and endorsement calendar to include all organizational press and communications rollouts.
Work with Campaigns Department to help with state and local campaign communications efforts, interact directly with campaigns to provide resources, guidance as needed;
Manage process by which materials are created for the communications department including, but not limited to, briefing materials, press releases, talking points, op-eds, etc.;
Create opportunities showcasing EMILY’s List staff, accomplishments, endorsed candidates, and mission that generates positive press coverage in varied outlets;
Be an aggressive and quick-thinking originator of stories to pitch on behalf of EMILY’s List and our endorsed candidates;
Serve as on-record spokesperson for the organization as needed;
Assist with booking, pitching process within the organization;
Perform other duties as assigned.
Qualifications
Must have experience in communications, working with press;
Experience in a rapid response media environment;
At least one cycle of campaign experience or state legislative press experience is strongly preferred;
Experienced manager of people and processes;
Ability to communicate effectively with diverse audiences and write quickly and in a compelling manner about multiple topics;
Energetic ability to multi-task and manage projects in a fast-paced and changeable environment; willingness to invest multiple teams and stakeholders in communications efforts;
Ability to use multiple mediums and approaches including new media to create multi-faced and effective campaigns;
Ability to work independently and collaboratively;
Commitment to electing pro-choice Democratic women;
Strong, determined team-player with ready sense of humor, thick skin, and a demonstrated willingness to work hard and take risks;
Commitment to the diversity of our candidates, membership, partners, and staff.
EMILY’s List offers a competitive salary and a strong benefits package. To apply, email resume and cover letter to commsjobs@emilyslist.org - subject line including your name and the job title. No calls, please.
EMILY’s List prohibits discrimination of employment, promotion, compensation, terms, conditions, or privileges of employment based on gender, disability, race, age, national origin, color, creed, sexual orientation, sex (including marital and parental status), gender identity and expression, religion, economic status, ethnic identity, veteran's status, or any other basis prohibited by applicable law.
EMILY's List is an Equal Opportunity Employer that values a multi-cultural, diverse working environment. Applicants of diverse backgrounds are welcomed and encouraged to apply.
Worcester County Food Bank
474 Boston Turnpike, Shrewsbury, MA, USA
COMMUNICATIONS & DEVELOPMENT ASSOCIATE – JOB POSTING SUMMARY: Worcester County Food Bank (WCFB) believes that food is a basic human right and that hunger is an issue of social justice. WCFB’s mission is to engage, educate, and lead Worcester County in creating a hunger-free community. To that end, WCFB annually collects 6.5 million pounds of perishable and non-perishable food and distributes it through a network of 118 Partner Agencies, including food pantries and community meal programs, trains Partner Agencies in food safety, and advocates for systemic and sustainable solutions to the problem of hunger. WCFB’s Communications & Development Associate will spend about 50% of their time executing upon a multi-faceted communications strategy: working to increase WCFB’s visibility and reach, and creating informative, engaging, and impact-focused communications (especially on social media). The other 50% they will be enmeshed in fund development: working closely with WCFB’s Development Coordinator and Development Manager to enter, process and acknowledge individual donor contributions. The Associate will be fully apprised of our various platforms and systems – from Constant Contact to Donor Perfect to WordPress – and become widely knowledgeable in all aspects of Communications & Development strategy, approach, and practice at WCFB. This is a full-time, non-exempt position reporting to the Director of Communications & Development. RESPONSIBILITIES: Branding, Brand Messaging, and Strategy Remains knowledgeable in and adheres to Communications Strategy and Brand Guidelines and supports staff and vendors to do the same In absence of, or at the direction of the Communications Coordinator, serves as a point of contact for vendors, such as designers, photographers, and videographers Remains knowledgeable in, and shares, best practices in communications and development; may attend trainings, workshops, and community meetings to inform strategies and approach Adheres to and updates WCFB’s Communications Calendar Digital Communications Designs and formats digital assets such as e-mail campaigns, social media, website graphics, and ads Sources mission-relevant content for social media and monthly e-news; as needed contributes original content to social media, e-news, and WCFB website Identifies new opportunities to showcase WCFB and Partner Agency stories utilizing our digital platforms Updates and monitors WCFB social media channels during normal business hours Makes real-time updates to WCFB’s Wordpress-based website Print Communications May support the development of print collateral including annual publications, handouts, invitations, tribute cards, marketing materials and ads May help to develop content for donor acknowledgement letters Gift Entry, Processing, Reporting and Acknowledgement Adheres closely to Mail, Cash/Check-Handling and Document Destruction & Retention policies Serves as primary back-up to Development Coordinator, processing payment and entering and updating gifts in Donor Perfect; follows standardized approach for recording and acknowledging gifts timely and accurately May pull and organize data and create reports to track results by donor segment; may create batch reports and lists to inform acknowledgement letters Provides excellent customer service to donors and other constituents, including processing gifts by phone and in-person at WCFB; fields questions from donors and donor prospects concerning giving/giving history Other Shares responsibility with colleagues in WCFB’s administrative office for answering calls and greeting visitors in absence of Administrative Coordinator May occasionally represent WCFB at corporate and community events and information sessions Performs other duties as assigned by supervisor or Executive Director QUALIFICATIONS: Bachelor’s Degree or relevant experience required, ideally with 2+ years of experience in communications or fund development position. Exemplary communication skills and strong attention to detail. Proficiency in Microsoft Office suite. Strong social media experience. Some experience in graphic design and mail programs (i.e. Constant Contact, Mail Chimp) preferred. Experience in Donor Perfect preferred. Understanding of and commitment to WCFB mission. Some local and regional travel and non-standard hours may be required for attendance at events and meetings (in such case, flex scheduling available). Salary Level: $ 19-$22 per hour. Status: Non-Exempt WCFB is an Equal Employment Opportunity (EEO) employer and welcomes all qualified applicants. Applicants will receive fair and impartial consideration without regard to race, sex, color, national origin, age, disability, veteran status, genetic data, or religion or other legally protected status.
COMMUNICATIONS & DEVELOPMENT ASSOCIATE – JOB POSTING SUMMARY: Worcester County Food Bank (WCFB) believes that food is a basic human right and that hunger is an issue of social justice. WCFB’s mission is to engage, educate, and lead Worcester County in creating a hunger-free community. To that end, WCFB annually collects 6.5 million pounds of perishable and non-perishable food and distributes it through a network of 118 Partner Agencies, including food pantries and community meal programs, trains Partner Agencies in food safety, and advocates for systemic and sustainable solutions to the problem of hunger. WCFB’s Communications & Development Associate will spend about 50% of their time executing upon a multi-faceted communications strategy: working to increase WCFB’s visibility and reach, and creating informative, engaging, and impact-focused communications (especially on social media). The other 50% they will be enmeshed in fund development: working closely with WCFB’s Development Coordinator and Development Manager to enter, process and acknowledge individual donor contributions. The Associate will be fully apprised of our various platforms and systems – from Constant Contact to Donor Perfect to WordPress – and become widely knowledgeable in all aspects of Communications & Development strategy, approach, and practice at WCFB. This is a full-time, non-exempt position reporting to the Director of Communications & Development. RESPONSIBILITIES: Branding, Brand Messaging, and Strategy Remains knowledgeable in and adheres to Communications Strategy and Brand Guidelines and supports staff and vendors to do the same In absence of, or at the direction of the Communications Coordinator, serves as a point of contact for vendors, such as designers, photographers, and videographers Remains knowledgeable in, and shares, best practices in communications and development; may attend trainings, workshops, and community meetings to inform strategies and approach Adheres to and updates WCFB’s Communications Calendar Digital Communications Designs and formats digital assets such as e-mail campaigns, social media, website graphics, and ads Sources mission-relevant content for social media and monthly e-news; as needed contributes original content to social media, e-news, and WCFB website Identifies new opportunities to showcase WCFB and Partner Agency stories utilizing our digital platforms Updates and monitors WCFB social media channels during normal business hours Makes real-time updates to WCFB’s Wordpress-based website Print Communications May support the development of print collateral including annual publications, handouts, invitations, tribute cards, marketing materials and ads May help to develop content for donor acknowledgement letters Gift Entry, Processing, Reporting and Acknowledgement Adheres closely to Mail, Cash/Check-Handling and Document Destruction & Retention policies Serves as primary back-up to Development Coordinator, processing payment and entering and updating gifts in Donor Perfect; follows standardized approach for recording and acknowledging gifts timely and accurately May pull and organize data and create reports to track results by donor segment; may create batch reports and lists to inform acknowledgement letters Provides excellent customer service to donors and other constituents, including processing gifts by phone and in-person at WCFB; fields questions from donors and donor prospects concerning giving/giving history Other Shares responsibility with colleagues in WCFB’s administrative office for answering calls and greeting visitors in absence of Administrative Coordinator May occasionally represent WCFB at corporate and community events and information sessions Performs other duties as assigned by supervisor or Executive Director QUALIFICATIONS: Bachelor’s Degree or relevant experience required, ideally with 2+ years of experience in communications or fund development position. Exemplary communication skills and strong attention to detail. Proficiency in Microsoft Office suite. Strong social media experience. Some experience in graphic design and mail programs (i.e. Constant Contact, Mail Chimp) preferred. Experience in Donor Perfect preferred. Understanding of and commitment to WCFB mission. Some local and regional travel and non-standard hours may be required for attendance at events and meetings (in such case, flex scheduling available). Salary Level: $ 19-$22 per hour. Status: Non-Exempt WCFB is an Equal Employment Opportunity (EEO) employer and welcomes all qualified applicants. Applicants will receive fair and impartial consideration without regard to race, sex, color, national origin, age, disability, veteran status, genetic data, or religion or other legally protected status.
Mapp Biopharmaceutical, Inc.
San Diego, California
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
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
