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 Director of Microbiology to support Ajinomoto Bio-Pharma Services’ manufacturing. This role directs and provides 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 Director, QC 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.)
- Creates and innovates at the strategic level, while managing diligent execution at the tactical level.
- Directs all quality control microbiology management 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 strategy 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. Will represent the company as the subject matter experts (SME) for microbiological matters and will address 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 recommendations for corrective action 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.
- Bachelor’s degree in a Life Sciences discipline or equivalent training and experience.
- Minimum of ten (10) years relevant experience in Quality Control Microbiology.
- Minimum of five (5) years of supervisory experience.
- Extensive experience with GMP, USP, EM, contamination control, aseptic techniques, aseptic processing 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.
Our leadership is fully committed to employee engagement and developing their team. You will be directing and providing expert knowledge in the strategic function of QC Microbiology.
Other Core Leadership Responsibilities:
- Develops short and long-term people and organizational strategy in alignment with Aji Bio-Pharma goals and direction.
- Leads with impact & influence. Establishes credibility, effectively persuades and develops others, and achieves important objectives collaboratively.
- Identifies, recruits, and retains top-notch talent.
- Champions Aji Bio-Pharma’s culture and empowers employees to take responsibility for their jobs and goals.
- Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
- Maintains transparent communication.
We provide a Total Rewards package designed to make life better – both at work and at home.
- Annual Bonus Opportunities for All Employees
- 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off
- Paid Parental Leave
- Annual Company Shutdown in December
- Comprehensive Medical, Dental + Vision
- 401K Company Match + Immediate Vesting
- Backup Daycare and Eldercare
- Monthly Employee Appreciation Events and Food Truck Fridays
- Employee Discount Programs
- Tuition Reimbursement
- Casual Dress Code
- Wellness Programs
- Community Outreach Opportunities
If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the “Careers” section. Please be sure to note where you saw our ad posting.
New hires will pass a background check and drug screen as a condition of employment.
We are 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.