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 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 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 Retir