Senior Associate, Drug Product Manufacturing Lead

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.
What You Will Achieve
We are seeking a highly motivated individual for the role of 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 t roubleshooting in ambiguous situations as well as technical solutions. Responsibilities also include support of compliance related activities, including GMP batch documentation, safety, training, and quality systems.
How You Will Achieve It
Project Management

• Simultaneously manages multiple drug product manufacturing campaigns to meet the needs of clinical project teams.
• Assesses manufacturing process capabilities to meet the project request and ensures suitable risk management /mitigation strategies are employed prior to and during manufacture.
• Works closely with cross-functional project team, including Global Clinical Supply, Quality Assurance, and Pharmaceutical Sciences colleagues to define clinical supply requirements and execute agreed project plans against deliverables.
• Coordinates and delivers GMP batch documentation prior to manufacture, ensuring all partner lines are in agreement with deliverables and project timelines.
• Ensures effective data management and knowledge capture throughout project lifecycle.
• Provide excellent customer service: share process knowledge, proactively communicates complex issues, and status updates.

Process Engineering:

• Provides technical support on manufacturing activities to ensure engineering controls and target product attributes are met.
• Drive the timely resolution of quality deviations and assist in root cause analysis or CAPAs for manufacturing investigations.
• Prepare data reviews and present learnings post-manufacture.
• Develop comprehensive process understanding of current drug product technologies, procedures and job demands.
• Supports data strategy for digital manufacturing.
• Propose and lead continuous improvement projects

Qualifications
Must-Have:

• Applicant must have Bachelor's degree in chemical or biomedical engineering and 3 to 5 years of experience OR Master's degree in Chemical or biomedical engineering or equivalent and 1 to 3 years of experience.
• Knowledge of industry practice for cGMP
• Project Management experience
• Excellent verbal and written communication skills

Nice-to-Have:

• Subject Matter Expertise on drug product manufacturing technologies, particularly for solid oral dosage forms.
• Experience with data visualization tools (ie. Spotfire, OSiPi, or Tableau)

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:

• This role is standard day Monday through Friday work shift ; some off-shift support needed when issues arise.

Other Job Details:

• Last day to Apply: October 10th, 2024
• Eligible for Relocation Assistance: No
• Work Location Assignment: 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.
Manufacturing
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