Senior Manufacturing Associate
Reports to: Manufacturing & Supply Chain Senior Manager
Location: Framingham Office US-based
Summary of Job Description:
The Senior Manufacturing Associate is responsible for executing the cGMP manufacturing operations to support the production of Replimune products at the Framingham, MA, facility. This individual will collaborate with multiple departments to support the manufacturing technology transfer and startup of the production facility and will assist with the generation/revision of Standard Operating Procedures and associated documentation to ensure manufacturing readiness.
- Author SOPs, batch records, deviations and change controls.
- Maintain the ability to aseptically gown and/or sterile gown as needed.
- Perform stocking and inventory of manufacturing supplies.
- Perform cleaning of process equipment and manufacturing suites.
- Ensure training requirements are kept up to date in operations being performed.
- Assemble, clean and autoclave process components and equipment.
- Prepare buffers and solutions following approved processes.
- Perform aseptic operations within Biosafety cabinets and clean room environment.
- Setup and operate single use technology production equipment for viral production, tangential flow filtration, chromatography, filtration and aseptic filling process steps.
- Become qualified and perform visual inspection of final product vials.
- Follow verbal and written procedures in performing processing steps and operating production equipment.
- Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements and accurately completes appropriate production documentation.
- Assist with the review of completed manufacturing documentation.
- Perform as Subject Matter Expert or system owner for specific pieces of equipment.
- Provide training to and review safety procedures with junior employees.
- Assist with establishing manufacturing training program.
- Support validation commissioning efforts for manufacturing equipment.
- Plan production activities within assigned area.
- Assist with routine maintenance of production equipment.
- May potentially work some weekends/holidays pending production
- Bachelor’s degree and 3 to 6 years of related work experience in cGMP biopharma manufacturing preferred or
- Associate degree or High School Diploma and 5 to 8 years of related work experience in cGMP biopharma manufacturing.
Experience and skill requirement:
- Minimum of 3 years working in positions in cGMP environment.
- Experience working in two or more functional areas (Cell Culture, Purification of Drug Substance, or aseptic filling of Product).
- Experience with single-use manufacturing technologies.
- Demonstrated ability to work in cross-functional teams across the business.
- Strong organizational skills and attention to detail.
- Excellent written and oral communication skills and strong team player.
- Ability to lift objects up to 50 pounds and stand for up to 3 hours at a time is required.
- Must be experienced with Microsoft Word and Excel.
EEO & Employment Eligibility:
Replimune 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, ancestry origin, disability or veteran status. Replimune 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.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition.
Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.