1+ months

Senior Associate, Drug Product Manufacturing Lead

Pfizer
Groton, CT 06340
**Why Patients Need You**



Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.



We are seeking a highly motivated individual for the role of Senior Associate Drug Product Manufacturing (DPM) Lead within Drug Product Supply (DPS) in Groton, CT. Our GMP facilities utilize advanced manufacturing engineering technology to produce clinical supplies for Phase I - III studies. The DPM Lead has an integral role in process engineering to facilitate the manufacture of solid dosage forms. As a manufacturing lead you will engage with cross-functional teams on technology transfers, prepare GMP documents, provide operational floor support as manufacturing/process engineer, and manage project timelines.



**What You Will Achieve**



As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.



**How You Will Achieve It**



**Project Support:**



+ Represent Drug Product Manufacturing on multiple cross-functional Pharm Sci Small Molecule early phase project teams.

+ Apply process engineering skillset in the scale-up of solid dosage forms from lab to GMP manufacturing scale (immediate release tablets, modified release tablets, microspheres, capsules, etc).

+ Create/review GMP documentation, including batch records, product specific cleaning assessments, and SOPs.

+ Liaise with partner lines to:

+ Rapidly translate lab scale formulations into robust GMP processes in partnership with formulation scientists.

+ Manage material requests (procurement and movement) with Inventory Management.

+ Ensure on-time test and release of clinical supplies with GMP analytical lab and Quality Operations.



**Technology and Capabilities:**



+ Provide operational floor support during manufacture to ensure engineering controls and target product attributes are met.

+ Support data review and present learnings post-manufacture.

+ Drive the timely resolution of quality deviations and assist in root cause analysis or CAPAs for manufacturing investigations.

+ Develop comprehensive process understanding of current drug product technologies, procedures and job demands.



**Leadership**



+ Provide excellent customer service through real time project status updates and timely communications.

+ Assure adherence to compliance and data integrity requirements.

+ Support / lead continuous improvement initiatives and implementation of new technology.



**Qualifications**



**Must-Have**



+ Bachelor's Degree in a Scientific or Engineering discipline.

+ 3+ years of experience.

+ Knowledge of industry practice for cGMP.

+ Excellent communication and organizational skills.

+ Self-motivated and regularly delivering towards timelines.



**Nice-to-Have**



+ Master's degree

+ Experience with solid dosage forms a plus.



**PHYSICAL/MENTAL REQUIREMENTS**



+ Standing, bending, climbing, reaching and lifting upward of 55 pounds may be required.

+ Personal Protective Equipment such as gloves, a full Tyvek suit and breathable air and/or filtering face piece may be required.



**Other Job Details:**



+ Eligible for Employee Referral Bonus: YES



**\#LI-PFE**



**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.



Manufacturing



\#LI-PFE

Categories

Posted: 2021-03-29 Expires: 2021-05-28

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Senior Associate, Drug Product Manufacturing Lead

Pfizer
Groton, CT 06340

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