Technical Specialist, Clinical Manufacturing
Job Description
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
The clinical manufacturing technical specialist is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. The initial focus of your role will be on the start-up of a new facility in support of facility/equipment commissioning and qualification, creation of necessary cGMP documentation, and training within the production support area. You will be part of a team responsible for the execution of upstream mammalian and microbial processes. You will coordinate and lead production operations on the manufacturing floor, including taking a lead role in the qualification of process equipment, supporting development, clinical, and launch activities. This role is a key communication and technical interface between the GMP manufacturing teams in the plant and our partner organizations.
As part of the Technical Operations team, your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.
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
Manage own time, professional development, and be accountable for own results.
Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.
Adhere to Good Manufacturing Practices and standard operating procedures, and material sampling instructions.
Execute downstream mammalian and microbial purification processes in a {Current} Good Manufacturing Practices {part of GxP} environment.
Responsible for the equipment preparation, formulation and filling of biologic drug products.
Complete recurring assignments independently and select the most appropriate method or approach to do so within prescribed limits of authority.
Identify opportunities for continuous improvements and enable implementation, utilize continues improvement and root cause analysis tools.
Maintain cross-functional communication with tech transfer team, quality and engineering.
Perform troubleshooting of production support equipment and operations.
Understand scientific principles in order to problem solve and troubleshoot test results.
Report any deviation or observation that might lead to adverse impact to product quality.
Complete work instructions and maintains clean room environment to comply with regulatory requirements.
Qualifications
Must-Have
High School Diploma or GED.
2+ years of experience.
Certification in assigned area, if applicable.
Demonstrated experience in a biotechnology manufacturing or laboratory environment.
Experience in cGMP (Current Good Manufacturing Practices) compliance as related to manufacture of biologics.
Ability to think critically and demonstrate troubleshooting and problem-solving skills.
Strong workload planning skills, organization, and attention to detail, and follow through.
Excellent written and verbal communication skills.
Strong computer skills in Microsoft Office required e.g. MS Word, MS Excel.
Nice-to-Have
Bachelor's Degree.
DS Purification experience.
PHYSICAL/MENTAL REQUIREMENTS
Ability to effectively gown into and operate in a clean room environment for extended periods of time. Gowning may include full coveralls, face mask, head cover, boots and gloves.
Ability to lift up to 25 lbs.
Ability to stand and walk for extended periods of time.
Ability to operate forklift or Master Mover for heavy loads.
Ability to perform algebraic mathematical calculations and follow Standard Operating Procedures.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to effectively gown into and operate in a clean room environment for extended periods of time. Gowning may include full coveralls, face mask, head cover, boots and gloves.
Ability to work non-standard hours as required including occasional evenings or overnights or weekends. Typical work schedule is 7AM – 330PM M-F. Non-standard hours are typically on a volunteer basis and are avoided when possible, however it is unavoidable at times.
There is no travel expected with this role.
Other Job Details:
Last Date to Apply: November 04, 2024.
Geography includes: USA - MA - Andover
Eligible for Relocation Package - NO
The salary for this position ranges from $28.68 to $47.79 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. 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.
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.
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.
