Together, Let's Make A Difference.
At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.
Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry's top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.
We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.
Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.
We are currently seeking a Senior Manager, Microbiology
who responsible directing and providing expert knowledge to the development, implementation, and maintenance of quality control microbiology systems and activities. This position oversees the development of microbial methods and procedures to ensure quality control goals are obtained. The Manager, Microbiology is responsible for the management of the cGMP QC Microbiology group and assures utilities, facilities, materials and products conform to company standards and satisfy global regulations (i.e. FDA, EMA, PMDA, etc.) Responsibilities:
- Drives performance and continuous improvement, while managing diligent execution of day to day performance.
- Manages all quality control microbiology activities including hiring, training, and developing QC micro personnel.
- Establishes and communicates high performance standards, defines clear accountability, and leads by adopting improvement strategies to reduce operational variances and increase efficiency.
- Creates and approves the validation process for new facilities and equipment.
- Manages departmental budget, headcount and capital.
- Sets short-term and long term department goals and deploys goals to the department staff.
- Coordinates QC micro functions with operation activities and cross departmental staff.
- Ensures implementation and maintenance of quality systems, including but not limited to, SOP writing, deviations, technical report review and personnel training.
- Interacts professionally with clients for process development, transfer, testing and monitoring activities. Represents the company as the subject matter experts (SME) for microbiological matters and addresses client inquiries.
- Represents department in internal and external audits. Responsible for resolution of audit deficiencies.
- Analyzes data and results and provides conclusions and proposals for final reports; capable of critical review.
- Performs investigations and makes for the corrective actions necessary to assure conformity with quality specifications.
- Oversees staff competency and /or training in all aspects of testing, cGMPs, SOPs (standard operating procedures), company policies and safety.
- Builds effective partnerships with department heads to help drive the business toward achieving company objectives.
- Regular and reliable attendance on a full time basis [or in accordance with posted schedule.
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Bachelor's degree in a Life Sciences discipline or equivalent experience required.
- Minimum of 7 years relevant experience in Quality Control Microbiology.
- Minimum of 5 years of supervisory experience.
- Significant experience with GMP, USP, EM, contamination control, aseptic techniques and troubleshooting.
- Demonstrated ability to manage, motivate and mentor scientific personnel and encourage teamwork.
- Detail oriented with strong written, verbal communication and presentation skills.
- Proficiency with Microsoft Office applications.
The anticipated salary range for candidates who will work in California is $111,416.20 - $155,827.70
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, type and length of experience within the industry, education, etc. Our Client is a multi-state employer and this salary range may not reflect positions that work in other states.
New hires will pass a background check and drug screen as a condition of employment.
Our Client is an EOE dedicated to a diverse work force and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. #LI-KC1