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Location: Mattapan, MA
Exempt/Non-Exempt: Non Exempt
Business Unit: MassBiologics
Department: MassBiological Labs - MassBiologics of UMMS - W416800
Job Type: Full-Time
Salary Grade: 05
Union Code: Non Union Position-W25-Non Unit Classified
Num. Openings: 2
Post Date: Dec. 31, 2020
SUMMARY OF POSITION:
Under the general direction of the Manager or designee, Manufacturing Associate II, Nucleic Acid Chemistry will primarily assist with the support of cGMP oligonucleotide manufacturing activities. Associate will participate with the manufacture, assembly, and labeling of APIs, clinical and commercial therapeutics, biologic drug substances and drug products. Operates manual, semi-automatic, and automated production equipment. Performs all functions under cGMP guidelines and any other duties assigned.
- Actively involved in the manufacturing of oligonucleotide APIs, therapeutic drug substances and drug products in GMP environment.
- May supervise manufacturing activities within the Nucleic Acid manufacturing.
- Actively involved in aspects of technology transfer and scale-up of oligonucleotide manufacturing processes.
- Perform manufacturing activities for a variety of clinical and commercial products when required for upstream and downstream unit operations within the vaccines, biologics and viral vector groups, drug product fill finish, visual inspection, packaging, and labeling.
- Write and revise standard operating procedures and batch records in accordance with regulatory and procedural guidelines.
- Collaborate with validations and engineering personnel to validate new equipment and facility.
- Partner with Manufacturing Management and Quality Assurance to resolve manufacturing problems such as deviations and incident reports
- Maintain, calibrate and troubleshoot critical process equipment.
- Ability to work in an aseptic environment.
- Perform autoclaving, cleaning and sterilization operations as needed.
- Ability to maintain records and logbooks using good documentation practices.
- Review executed documents and assist in the tabulation of data and report generation if required.
- Assist in training of manufacturing operators.
- Prepare buffers, reagents and solutions as required to support manufacturing activities.
- Other duties and/or projects as assigned.
- B.S. in chemistry, a related scientific discipline, or equivalent combination of education/experience.
- 2-4 years of relevant manufacturing experience, pharmaceutical manufacturing experience preferred.
- Previous knowledge of oligonucleotide synthesis, LC, UF/DF, conjugation, MS/MS is adventitious.
- Ability to follow SOPs and batch records precisely, recognize deviations, and recommend corrective action within scope of training.
- Prior experience in a cGMP regulated environment with working knowledge of regulatory guidelines. FDA regulated manufacturing environment is highly desired.
- Familiarity with UNICORN software and proficient in MS Word, Excel and other relevant electronic systems
- Capable of moderately complex troubleshooting.
- Strong problem solving, time management and organizational skills.
- Demonstrated ability to consistently meet project deadlines.
- Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills.
- Excellent written and verbal communication skills. Ability to communicate effectively with others and to train others.
- Self-starter with demonstrated initiative through previous experience.
- Ability to work effectively both independently and as a member of a team.
- Experience in the following areas is highly desired: solid phase synthesis, nucleic acid modifications, and purification
- Occasional travel between functional operating MBL sites may be required. Standard work hours may include weekend and off shift hours as required. Must be able to work flexible hours to meet organizational needs.
- Must be able to lift 50 lbs. maximum using proper lifting technique.
- Experience in the following areas is preferred: solid phase synthesis, nucleic acid modifications, and purification of oligonucleotides
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