What are the responsibilities and job description for the Manufacturing Manager position at Genezen?
JOB SUMMARY
Promote a safe working environment, training, and development of the manufacturing team; plan on-time execution of batch activities; deliver quality product; and continuously improve manufacturing processes.
ESSENTIAL JOB FUNCTIONS
- Provide leadership, coaching, and mentoring to the Manufacturing organization across multiple shifts
- Hire, coach, and develop Manufacturing team members, including performance management and periodic reviews
- Plan, direct, and oversee Vector Manufacturing activities including the scheduling of resources, material staging, equipment preparation, batch execution, cleaning/sanitization, inventory transactions, and batch record review
- Complete on-time delivery of product to clients, including review of Manufacturing records and investigations
- Monitor and report on area performance, identifying opportunities for improvement and implementing process improvements
- Design, implement, maintain, and continuously improve vector manufacturing systems, policies, procedures, and programs that ensure compliance to company and regulatory body standards for Quality and EHS
- Identify and mitigate risks in Manufacturing operations that could negatively impact product and personnel safety
- Represent the Manufacturing function during client and regulatory audits
- Work collaboratively with cross functional teams in engineering, process development, project management, etc. to facilitate a successful customer experience
- Manage the Manufacturing Production system including but not limited to personnel development, problem solving, investigation of issues, root cause analysis, CAPA, 5S, visual factory, etc.
- Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the Manufacturing department
SPECIAL WORK REQUIREMENTS
- Willingness to occasionally work nights and weekends required, with the ability to address unplanned facility situations as they arise
- Criminal background check required
- Other duties as assigned
KNOWLEDGE, SKILLS AND EXPERIENCE
EDUCATION / CERTIFICATIONS / LICENSES |
Essential/Desired |
BS in Biology, Chemistry or Engineering |
Desired |
In-depth knowledge of aseptic processing |
Essential |
ON-THE-JOB EXPERIENCE |
|
5 to 10 years of related work experience in a GMP environment |
Essential |
2 to 5 years of supervisory experience |
Essential |
Drug Substance experience with cell culture and upstream/downstream processing |
Strongly Desired |
Experience using single use systems |
Desired |
SKILLS / ABILITIES |
|
Demonstrated interpersonal skills to build relationships, act as change agent, manage conflict, and adapt to rapidly changing organizational and business needs |
Essential |
Ability to manage multiple priorities |
Essential |
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to work in a BSL 2 environment with personal protective equipment.
- While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
- In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.
- While performing the duties of this job, the employee must be aware of potential exposure to moving mechanical parts; high, precarious places; toxic or caustic chemicals; high noise areas, and risk of electrical shock.
- A physically able individual is required who can spend time on the floor during activity execution (maintenance, construction, commissioning and qualification).