Senior Associate, Technical Operations

POSITION SUMMARY:
The incumbent is responsible for supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role is primarily responsible for performing daily manufacturing operations. The role will also be responsible for supporting additional manufacturing responsibilities.

KEY ROLE AND RESPONSIBILITIES:

Execute the Day-to-Day Manufacturing Processing
• Assist in development and implementation of GMP SOPs related to Manufacturing Operations.
• Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients.
• Maintain production facilities at a high standard of cleanliness and organization.
• Perform equipment maintenance and calibrations as required.
• Maintain appropriate level of training for assigned responsibilities.
• Identify and report risks in the manufacturing areas that could negatively impact the quality of patient therapies.
• Ensure timely review and closure of electronic batch records, exceptions, deviations.
• Assist with CAPA and change controls as needed.

Collaborate Effectively
● Be a team player, offer assistance, and respond well to requests for help from team members.
● Use strong communication and build relationships.
● Demonstrate technical acumen, operational understanding, and GMP compliance.
● Support operational excellence initiatives.
● Support a culture of safety and GMP compliance.
● Identify opportunities for continuous improvement.

PREFERRED EDUCATION: 
• BSc degree in a relevant field (e.g. biochemistry, chemical engineering, bioengineering, or related scientific field)

PREFERRED EXPERIENCE: 
• Minimum of 6 years’ experience in GMP biopharmaceutical operations preferably with experience in cell therapy, mammalian cell culture, and/or microbial fermentation.
• Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).
• Experience with electronic systems such as MES and ERP.

KNOWLEDGE, SKILLS AND ABILITIES:
• Familiar with regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, and viral vectors for clinical phase therapies.
• Proven track record in cGMP manufacturing operations, including producing therapies safely and right the first time.
• Fast learner, adaptable, and excellent cross-collaboration and inter-personal skills.
• The desire and ability to work in a fast-paced, start-up environment.

PHYSICAL REQUIREMENTS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:
• Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable.
• Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe nonsterile and sterile gowns.

SHIFT WORK, WEEKEND WORK AND HOLID