Pfizer Groton , CT 06349
Posted 1 week ago
Why Patients Need You
Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Chemical Research and Development
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. 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.
We are seeking a Manufacturing Logistics Technical Expert to join the CRD Manufacturing team in Groton CT. As part of the Operations team, Technical Experts are involved in the coordination, execution and manufacture of novel clinical API supplies under GMP. The successful Manufacturing Logistics Technical Expert will perform operations to manufacture GMP API as described in the batch record and manage the waste characterization for disposal. The Technical Expert collaborates with engineers, chemists, process supervisors and analysts to execute project manufacture in the regulated manufacturing areas. Given the dynamic team environment, strong interpersonal and communication skills are essential.
How You Will Achieve It
Subject matter expert to execute workflow and achieve alignment with CRD-M Process Supervisors on Hazardous Waste Characterization for Kilo Lab scale, batch and flow processes
Single point of accountability for large volume chemical hazard identification prior to disposal
Manage timelines in response to portfolio and technology demand prioritization
Responsible for materials and consumables management/requisitioning to support facility operations as specified by CRD-M Portfolio Lead
Under general supervision and working within defined operation parameters, conducts hands-on manufacturing of bulk organic synthesis in the Kilo Lab
Utilizes cGMP procedures and safe handling techniques of reactive chemicals, intermediates, solvents and waste streams during processing
Develop technical expertise of the design of the CRD manufacturing areas, equipment and utilities, the quality systems used in manufacturing, and the composition and workflows of the operations team
Reads, understands and records all information in GMP batch records as well as laboratory notebooks and maintains accurate records with an absolute focus on quality, compliance and safety
Sound grasp of basic mathematical calculations (e.g., ability to calculate volumes, areas and density conversions) is required
Cleans and maintains mechanical and processing equipment as needed while supporting a GMP qualified maintenance program
Process and equipment troubleshooting
Qualifications
Must-Have
Minimum: High school diploma or equivalent and at least 6 years experience in manufacturing with a strong preference for experience with GMP API manufacturing
Certification in assigned area if applicable.
Knowledge of industry practice for cGMP.
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Problem solving and trouble shooting skills.
Strong workload planning skills and organization.
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
Nice-to-Have
B.A./B.S, in Science or Engineering, or equivalent
Experience with Quality Management and Change Management Systems.
Proficient knowledge of cGMP and process safety
Mechanical aptitude a plus as this is a "hands-on"
Experience with lab automation software (e.g. Delta V)
Working knowledge of chemical engineering principles including; reaction kinetics, thermodynamics, heat and mass transport, and equipment design
PHYSICAL/MENTAL REQUIREMENTS
2:30pm) and 2nd Shift (2:30pm
11:00pm), with overtime as needed.
Ability to perform mathematical calculations
Ability to lift 50 pounds
Work Location Assignment: On Premise
The salary for this position ranges from $31.82 to $53.04 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
Connecticut
Groton 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.
Manufacturing
Pfizer