Technical Expert, Clinical Manufacturing, Fermentation in Andover, MA 01810

 
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 Job Summary

Job Title: Technical Expert, Clinical Manufacturing, Fermentation

Job Code: SA-PFE-PGS-4913258

Job Location: Andover, MA 01810

Job Date: 6/10/2024

Duration: PERM

Shift(s): 07:00 AM - 03:30 PM

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 Job Description

SourceAbled is seeking candidates for a Direct Hire role as a Technical Expert, Clinical Manufacturing, Fermentation with our client Pfizer, one of the world’s largest pharmaceutical companies. Seeking candidates in Andover, MA or willing to relocate.

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 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. 

  

Qualifications  

Must-Have 

  • High School Diploma or GED and 6+ years of experience.  

  • Certification in assigned area if applicable. 

  • Knowledge of industry practice for cGMP.  ?

  • Problem solving and trouble shooting skills. 

  • Strong workload planning skills and organization. 

  • Demonstrate excellent interpersonal and team building skills.

 

Nice-to-Have 

  • Bachelor’s Degree.  

  • 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.

 

PHYSICAL/MENTAL REQUIREMENTS

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

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.


Work Location Assignment: On Premise

 

 

 

The salary for this position ranges from $35.31 to $58.85 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

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.  

 

To find out more about Rangam, SourceAbled, and this role, click the apply button.

"An Equal Opportunity Employer M/F/D/V"

 About SourceAbled

SourceAbled, a proprietary workforce solution powered by Rangam, goes beyond a traditional job placement program. It provides a collaborative, holistic solution implemented to develop an inclusionary program and a culture of belonging by matching Fortune 500 companies with neurodivergent talent seeking to build and sustain successful and fulfilling careers. SourceAbled connects individuals with autism, neurodivergence, physical disability, and a wide range of cognitive differences such as ADHD, autism, dyslexia, dyspraxia, and dyscalculia to apply for jobs with employers in the USA, UK, Ireland, and India, who are actively seeking talents with disabilities. SourceAbled facilitates the coordination and management of diverse hiring programs, with a consultative approach, including training, and brings them to life through digitizing the experience of attracting, onboarding, supporting, and retaining qualified employees with autism and disabilities. The program uses an end-to-end, tech-enabled hiring program to build a connected inclusive community in the workplace for neurodivergent talent. It is designed to attract and place qualified job seekers as businesses look to establish, build, and maintain their disability inclusion practices and establish and nurture a culture of inclusion.

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