Technical Expert, Clinical Manufacturing
Job posting number: #7115795 (Ref:4859449)
Posted: November 10, 2022
Application Deadline: Open Until Filled
Job DescriptionWhy 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 size clinical batches for investigational study purposes. Your work will involve chemical or biological manufacturing, which typically includes media preparation, fermentation, cell culture, buffer preparation, purification and aseptic operations, prepares and autoclaves glassware and components.
As part of the Technical Operations team, you are recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will make decision 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 healthcare 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 product according to approved batch records.
Perform analytical in-process testing using techniques based on process instruction.
Exhibit broad working competence level for all core operating tasks and exhibit knowledge and ability to operate more complex processing equipment [Hiring manager to add examples].
Recognize environmental protection needs, setting up carbon canister and scrubbing equipment for process specific requirements.
Contribute to the review and implementation of the compliance and EHS (Environment, Health and Safety) practices in the plant.
Validate, qualify and commission requirements for 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.
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 experience in Biotech
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.
Be able to handle work load and responsibilities with minimum supervision.
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.
Experience working in a regulated environment.
Ability to effective gown into and operate in a clean room environment. Gowning may include coveralls, head cover, face mask, boot coverings and gloves.
Be able to lift up to 25 + lbs and ability to stand and walk for extended periods of time.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Be able to work during non standard hours and weekends.
This is a second shift position 2:00PM – 10:30PM Monday through Friday.
Other Job Details:
Work Location Assignment: On Premise. colleagues work in a Pfizer site because it’s needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.
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.