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Antibody Drug Conjugate (ADC) Molecule Analytical Product Specialist
- United States - Massachusetts - Cambridge
Full time
Posted 1 Days Ago
4924584
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 “4924584” as the “Keyword,” and click “Search.” No calls please.
Note: Salary $175,000.00 per year
The annual base salary for this position ranges from $117,300.00 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.
Breakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Global Supply
Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.
With an unwavering commitment to ensuring the availability and accessibility of these life-saving medications, we play a pivotal role in reaching patients, healthcare professionals, and markets across the globe.
Our network of state-of-the-art manufacturing facilities, strategically located distribution centers, and streamlined logistics systems enables us to deliver Pfizer's medicines with utmost efficiency and reliability, making a tangible difference in patients' lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)