Technical Associate, Clinical Manufacturing

Sourceabled; Andover (MA); On-site; USD 33,000 - 55,000; Full time

Benefits offered by this job

401(k) matching

Paid vacation/holiday/personal days

Parental/caregiver leave

Health benefits

Job summary

Pfizer is seeking a manufacturing professional to contribute to our solid dosage production and quality systems on site in Massachusetts. You will operate, maintain, and document processes supporting continuous manufacture with PCMM and cGMP practices.

You will collaborate with tech transfer, quality, and engineering teams, fulfill documentation responsibilities, and participate in process improvements while adhering to safety and regulatory requirements.

Qualifications

• High School Diploma or GED with 2+ years of relevant experience.
• Demonstrated experience in a biotechnology manufacturing or laboratory environment.
• Operational knowledge of computerized systems.
• Familiarity with Production Control Systems, ERP Systems, and other business systems.
• Demonstrated capability to work as a team member in a matrix development team.
• Excellent oral and written communication skills.
• Proficiency in Microsoft Office Suite.

Responsibilities

• Take responsibility for individual contributions to achieve team deliverables, working effectively as a team member and coordinating with others.
• Manage personal time and professional development, being accountable for results.
• Follow standard procedures to complete tasks of varying scope, sequence, and complexity within the agreed timeframe.
• Identify and solve moderately routine problems.
• Complete assignments with moderate supervision using established procedures, referring deviations from standard procedures to the supervisor.
• Ensure work is reviewed for accuracy, quality, and adherence to standards.
• Engage in cross-functional communication with the tech transfer team, quality, and engineering as needed, and support continuous improvement initiatives using root cause analysis tools.
• Implement Current Good Manufacturing Practices (part of GxP) and safe handling techniques for solid dosage processing within the continuous manufacture/PCMM work stream.
• Perform Operator care tasks associated with the maintenance and operation of complex pharmaceutical manufacturing equipment.
• Generate, assist, and execute documentation related to solid dosage manufacture, including working batch record documentation and in-process run sheets.

Skills

Biotech manufacturing

Computerized systems

Production Control Systems

ERP Systems

Team collaboration

MS Office

Education

High School Diploma or GED

Tools

Production Control Systems

ERP Systems

Job description

Use Your Power for Purpose

Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need.

What You Will Achieve

• Take responsibility for individual contributions to achieve team deliverables, working effectively as a team member and coordinating with others.
• Manage personal time and professional development, being accountable for results.
• Follow standard procedures to complete tasks of varying scope, sequence, and complexity within the agreed timeframe.
• Identify and solve moderately routine problems.
• Complete assignments with moderate supervision using established procedures, referring deviations from standard procedures to the supervisor.
• Ensure work is reviewed for accuracy, quality, and adherence to standards.
• Engage in cross-functional communication with the tech transfer team, quality, and engineering as needed, and support continuous improvement initiatives using root cause analysis tools.
• Implement Current Good Manufacturing Practices (part of GxP) and safe handling techniques for solid dosage processing within the continuous manufacture/PCMM work stream.
• Perform Operator care tasks associated with the maintenance and operation of complex pharmaceutical manufacturing equipment.
• Generate, assist, and execute documentation related to solid dosage manufacture, including working batch record documentation and in-process run sheets.

Here Is What You Need (Minimum Requirements)

• High School Diploma or GED with 2+ years of relevant experience
• Demonstrated experience in a biotechnology manufacturing or laboratory environment
• Operational knowledge of computerized systems
• Familiarity with Production Control Systems, Enterprise Resource Planning Systems, and other business systems
• Demonstrated capability to work as a team member in a matrix development team
• Excellent oral and written communication skills
• Proficiency in Microsoft Office Suite

Bonus Points If You Have (Preferred Requirements)

• Solid understanding of fermentation and downstream processing techniques
• Experience with cGMP production of phase I/II clinical drug substances
• Experience in commissioning and qualifying process equipment
• Ability to execute microbial upstream and downstream processes
• Strong problem-solving skills
• Strong organizational skills and attention to detail
• Familiarity and basic understanding of common AI tools and a curiosity for learning how they can be used to enhance productivity

PHYSICAL/MENTAL REQUIREMENTS

• Must be able to climb flights of stairs, and remain standing for extended periods of time.
• Must be able to lift up to 50 lbs
• Ability to thrive in dynamic team environment with diverse perspectives

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Ability to work nights and weekends as needed depending upon process needs; nonroutine.
• Work Location Assignment: On Premise

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.

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 applies only to the United States - Massachusetts - Andover location.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

It is the policy of Rangam Consultants, Inc. to provide equal employment opportunities to all applicants and employees without regard to any legally protected status such as race, color, religion, gender, national origin, age, disability or veteran status.

The salary for this position ranges from $24.22 to $40.36 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies.