Manufacturing Associate - Contract - Philadelphia, PA
Proclinical is working alongside a CMO company seeking a Manufacturing Associate for a contract role in Philadelphia, PA. This position focuses on supporting gene therapy manufacturing processes within a Contract Manufacturing Organization (CMO). The role requires attention to detail, adherence to compliance standards, and the ability to work in a regulated environment.
Primary Responsibilities:
The successful candidate is a meticulous and dedicated professional with experience in gene therapy manufacturing. You will be responsible for ensuring compliance with all regulatory standards, maintaining detailed records, and supporting the overall manufacturing process. Your ability to work effectively in a regulated environment and your commitment to quality will be key to your success in this role.
Skills & Requirements:
- High School diploma with relevant experience or an Associate's/bachelor's degree in science with equivalent experience.
- Ability to perform arithmetic calculations and basic algebraic and geometric calculations accurately.
- Good vision, depth perception, and ability to distinguish colors.
- Ability to wear clean room attire and Personal Protective Equipment (PPE).
- Comfortable working in a production environment with potential exposure to noise, equipment hazards, chemicals, and allergens.
- May require medical testing as per Occupational Health Program.
- Willingness to work holidays and shifts as needed.
- Proficient in oral and written communication skills.
- Proficient in Microsoft Excel, Word, and Outlook.
- Ability to read, write, and understand English.
The Manufacturing Associate's responsibilities will be:
- Understand and apply aseptic technique concepts.
- Operate and maintain manufacturing equipment.
- Prepare solutions and materials for production.
- Participate in technical transfer and validation activities.
- Receive, organize, and manage materials, identifying any discrepancies.
- Utilize support systems such as LIMS.
- Collect and record scientific and process data following good documentation practices.
- Follow compliance and regulatory requirements, including cGMPs.
- Execute Standard Operating Procedures (SOPs) and Batch Records (BRs).
- Contribute to the development of technical documents, including non-conforming events and deviations.
- Suggest continuous improvement ideas and identify technical problems.
- Participate in regulatory inspections and client audits.
- Crosstrain in other areas and perform job functions across the site as needed.
- Perform well under direct supervision.
If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
