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Sr. Associate, Drug Product Manufacturing Lead
4 months ago
Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action.
What You Will Achieve
As a Sr. Associate Drug Product Manufacturing (DPM) Lead within Drug Product Supply (DPS) in Groton, CT, the successful candidate will help lead the manufacturing campaigns for Clinical Drug Product. The colleague will project manage complex development and clinical manufacturing activities, acting as the client interface on cross-functional teams. Colleague will provide troubleshooting in ambiguous situations as well as technical solutions. Responsibilities also include support of compliance related activities, including GMP batch documentation, safety, training, and quality system.
How You Will Achieve It
* Project Support:
* Represent Drug Product Manufacturing on multiple cross-functional Pharm Sci Small Molecule clinical project teams.
* Apply process engineering skillset in the scale-up of solid oral dosage forms from lab to GMP manufacturing scale (immediate release tablets, modified release tablets, microspheres, capsules, etc.)
* Author/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 Global Materials Management
* Ensure on-time test and release of clinical supplies with GMP analytical lab and Quality Operations.
* Support the planning and scheduling of clinical, development, and PM/Cal activities in DPM.
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 or Master's Degree in Chemical, Biomedical, Bio-engineering, or equivalent discipline
* 3+ years of experience in pharmaceutical / medical device setting
* Knowledge of Good Manufacturing Practices
* Excellent communication (verbal and written) and organizational skills.
* Self-motivated and regularly delivering towards timelines.
* Project management experience.
Nice-to-Have
* Experience with solid dosage forms
* Experience with scheduling
* Experience with data visualization tools (e.g., Spotfire)
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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
* Groton site presence is required for this role.
* Support of off-shift and weekend manufactures when necessary.
Work Location: On Premise
The annual base salary for this position ranges from $74,900.00 to $124,800.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. 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.
Engineering
