Technical Expert, Clinical Manufacturing, 3rd Shift
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
In your role, you will perform operations that are required for the production of
non-commercial clinical batches. Your work will involve chemical or biological manufacturing, which typically includes media preparation, fermentation, cell culture, buffer preparation, purification and aseptic operations, preparing autoclave and glassware and components.
As part of the Technical Operations team, you are recognized as a subject matter expert with specialized knowledge and skills in GMP practice, procedures, techniques, tools, materials and equipment. You will be entrusted with adapting standard methods and procedures by applying your knowledge prior work experience within requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will make decisions about the methods and procedures that are the best fit for different work situations. You will train others and reinforce behaviors that will help us achieve our goal of providing the best medicines to our patients.
It is your hard work and focus that will make 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, allocate work to others, and assist in establishing their priorities.
Support/perform support operations in the manufacture of clinical drug substance per GMP procedures.
Perform in-process testing using instruments and techniques based on process instruction and training.
Exhibit broad working competence level for all core operating tasks and exhibit knowledge and ability to operate more complex processing equipment [bioreactors, fermentors, chromatography skids, filtration skids].
Contribute to the review and implementation of compliance and EHS (Environment, Health and Safety) practices in the plant.
Validate, qualify, and commission equipment used in cGMP (current Good Manufacturing Practices) operations.
Coordinate and oversee the daily work of operations team members, when directed by Operations Manager or Leads. May serve as the delegate for Operations Lead.
Collaborate with Quality, Engineering, Process Development, Validation, and Operations to resolve manufacturing events in a timely manner.
Assure appropriate escalation to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
Remain current on all training requirements and complete all required procedural and skills training prior to executing assigned tasks.
High School Diploma or GED, and 6+ years of professional experience.
Thorough knowledge of industry practice and cGMP regulations. Experience working in a highly regulated environment.
Mechanical and technical aptitude. Demonstrated strong problem-solving and troubleshooting skills.
Strong knowledge in various drug substance manufacturing disciplines, such as buffer/media preparation, autoclave and equipment washer use, mammalian or fermentation upstream processing and downstream purification techniques [chromatography methods, filtration techniques, bulk filtration and filling]
Strong workload planning skills and organization.
Demonstrate excellent interpersonal and team building skills. Team oriented attitude and ability to thrive in dynamic environment. Change agile
Strong Electronic Skills working with computers, databases, software, navigation of shared drives, search engines, word processing, spreadsheets.
Experience with Quality Management and Change Management Systems.
Ability to effectively gown into and operate in a clean room environment. Gowning may include coveralls, head cover, face mask, boot covers, gloves.
Ability to lift 25+ lbs.
Ability to stand and walk for extended periods of time.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This is an overnight / 3rd shift position.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer 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 EligibilityPfizer 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.Manufacturing#LI-PFE