Manage analytical characterization and validation for antibody drug conjugates. Collaborate across teams and oversee regulatory submissions and stability studies.
Pfizer Inc. is seeking a Antibody Drug Conjugate (ADC) Molecule Analytical Product Specialist in Cambridge, MA.
Manage transfer and validation of analytical characterization release assays for antibodies and antibody drug conjugate products that are in clinical development and are commercial products. Ensure that the experiments are designed in accordance with ICH2 guidelines. Collaborate with internal teams in process development, manufacturing, quality, regulatory, supply chain, and with external CDMOs to advance mAb, DS, DP and FDP milestones efficiently. Identify and manage measurement of critical quality attributes (CQA) for antibodies, cytotoxic compounds and antibody drug conjugates to ensure safety and efficacy of the drug. Provide strategic input to design and maintain stability studies for pipeline and commercial programs. Lead the coordination and support for the analytical and quality (validation of analytical procedures) sections of regulatory submissions to global health agencies. Support key quality tasks for handling and use of cytotoxic compounds (auristatin and camptothecin) to enable use in manufacturing and process development.
Requires: Master's degree (or foreign equivalent) in Chemical Engineering or related sciences, plus 5 years of experience with complex Antibody Drug Conjugate (ADC) Oncology molecules in cytotoxic compounds. Also requires 3 years of relevant work experience with/using the following (which may have been gained concurrently):Performing, developing and managing analytical characterization techniques for antibodies and antibody drug conjugates; Chromatography, electrophoresis, spectroscopy, calorimetry, ELISA, immunological activity assays, PCR, lab automation, glycan analysis; Performing and managing analytical method transfers and analytical method qualifications; Authoring, reviewing of protocols, performing data analysis and authoring, reviewing reports; ICH Q2 (Analytical Validation) regulations & design of method transfers; Authoring, reviewing and managing analytical characterization sections for antibodies and antibody drug conjugates for regulatory filings; Performing and managing extended antibody drug conjugate product characterization activities; Performing and managing stability studies to determine product shelf life and track critical quality attributes (CQA); Support the process development and manufacturing of antibodies and antibody drug conjugates; Creating timelines and integrated project plans for analytical method development, transfer, qualification and validation, product release and stability testing; Leading project teams and working in matrix project teams to progress antibodies and antibody drug conjugates through varying phases of development through to commercialization; Managing critical reagents required for analytical characterization of antibodies and antibody drug conjugates; Managing resource forecast and capital, operational expenditure forecasts for analytical activities.
To apply, go to https://pfizer.wd1.myworkdayjobs.com/PfizerCareers . Scroll down, click " Search jobs ," enter "4925319" as the " Keyword ," and click " Search ." No calls please.
Note : Salary $124,842.00 to $195,500.00 per year
The annual base salary for this position ranges from $124,842.00 to $195,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Quality Assurance and Control
#LI-PFE
Manage transfer and validation of analytical characterization release assays for antibodies and antibody drug conjugate products that are in clinical development and are commercial products. Ensure that the experiments are designed in accordance with ICH2 guidelines. Collaborate with internal teams in process development, manufacturing, quality, regulatory, supply chain, and with external CDMOs to advance mAb, DS, DP and FDP milestones efficiently. Identify and manage measurement of critical quality attributes (CQA) for antibodies, cytotoxic compounds and antibody drug conjugates to ensure safety and efficacy of the drug. Provide strategic input to design and maintain stability studies for pipeline and commercial programs. Lead the coordination and support for the analytical and quality (validation of analytical procedures) sections of regulatory submissions to global health agencies. Support key quality tasks for handling and use of cytotoxic compounds (auristatin and camptothecin) to enable use in manufacturing and process development.
Requires: Master's degree (or foreign equivalent) in Chemical Engineering or related sciences, plus 5 years of experience with complex Antibody Drug Conjugate (ADC) Oncology molecules in cytotoxic compounds. Also requires 3 years of relevant work experience with/using the following (which may have been gained concurrently):Performing, developing and managing analytical characterization techniques for antibodies and antibody drug conjugates; Chromatography, electrophoresis, spectroscopy, calorimetry, ELISA, immunological activity assays, PCR, lab automation, glycan analysis; Performing and managing analytical method transfers and analytical method qualifications; Authoring, reviewing of protocols, performing data analysis and authoring, reviewing reports; ICH Q2 (Analytical Validation) regulations & design of method transfers; Authoring, reviewing and managing analytical characterization sections for antibodies and antibody drug conjugates for regulatory filings; Performing and managing extended antibody drug conjugate product characterization activities; Performing and managing stability studies to determine product shelf life and track critical quality attributes (CQA); Support the process development and manufacturing of antibodies and antibody drug conjugates; Creating timelines and integrated project plans for analytical method development, transfer, qualification and validation, product release and stability testing; Leading project teams and working in matrix project teams to progress antibodies and antibody drug conjugates through varying phases of development through to commercialization; Managing critical reagents required for analytical characterization of antibodies and antibody drug conjugates; Managing resource forecast and capital, operational expenditure forecasts for analytical activities.
To apply, go to https://pfizer.wd1.myworkdayjobs.com/PfizerCareers . Scroll down, click " Search jobs ," enter "4925319" as the " Keyword ," and click " Search ." No calls please.
Note : Salary $124,842.00 to $195,500.00 per year
The annual base salary for this position ranges from $124,842.00 to $195,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Quality Assurance and Control
#LI-PFE
Top Skills
Calorimetry
Chromatography
Electrophoresis
Elisa
Glycan Analysis
Immunological Activity Assays
Lab Automation
Pcr
Spectroscopy
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