Drug Product Finishing Group Lead

Why join Ajinomoto Bio-Pharma?

Our mission is to help improve the health of humankind.

We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique environment in which the work we do every day plays a crucial role in society.

We hope to inspire employees to come to work engaged and ready to give their all. This allows Ajinomoto Bio-Pharma to meet the commitments it makes to partners, patients and employees.

Total Rewards package designed to make your life better:

We offer health benefits, annual performance bonus, generous paid time off, paid parental leave, matching 401k contributions (immediate vesting), tuition reimbursement, employee discount program and much more!

Your next career move:

We are currently seeking a Drug Product Finishing Group Lead that manages operations and processes within Drug Product Finishing. Tasks include but are not limited to offloading, counting, sample submission, inspection, labeling and packaging and other projects as assigned. The Group Lead directly provides guidance to employees to ensure operations follow SOP's in a cGMP environment and provides general supervision over a work group, assigning tasks and checking work at regular intervals. The Drug Product Finishing Group Lead must also complete training and pass qualification related to Visual Inspection and Packaging. Other key responsibilities may include working closely with outside vendors and other departments, assisting in investigations, training operators, and writing/approving Maintenance Work Requests, Engineering and Facility Change Requests, and Purchase Requisitions.

Responsibilities:

• Leads day to day work of others; assists in managing performance, developing employees.
• Train and qualify new employees in routine Drug Product Finishing tasks under the guidelines of established SOPs and cGMP regulations.
• Lead Drug Product Finishing activities.
• Manage administrative duties of direct reports such as, timecards, attendance tracking, etc.
• Ensure manufacturing documentation and areas are in an audit ready state.
• Communicate shift project status to leaders.
• Monitors and communicates production metrics.
• Coordinate Pre/Post-line clearance and Equipment clearance with Leads and QA.
• Document observational findings regarding Drug Product Finishing operations.
• Provide training, answer questions, and feedback in real-time.
• Recording batch record documentation and review of finished product documentation for completeness and accuracy.
• Review and verify document entries and data meets SOP and GDP requirements.
• Assigning tasks to operators as required by the project scope.
• Document and communicate with Finishing Management (Supervisor and above) regarding personnel issues in real time.
• Document the status of assigned projects at the end of shift.
• Execute any and all tasks, in Drug Product Finishing Operations, as assigned, for which they are currently qualified. Tasks include but are not limited to offloading, counting, sample submission, inspection, labeling and packaging and product transfers to Materials Management.
• May participate in the interview and selection of potential Drug Product Finishing candidates.
• Participates in 1:1 sessions between Supervisors and lead's direct reports.
• Generate purchase requests for material/equipment utilized by Finishing Department.
• Perform batch record review to meet GDP requirements.
• Generate work orders in electronic Maintenance system.
• Provides technical support to Investigations team as a Subject Matter Expert.
• May interact with client auditors as Drug Product Finishing and cGMP subject matter expert.
• Special projects as assigned by Management.
• May support in the development, implementation and operation of alternate technologies, including semi-automated and automated equipment, and high voltage leak detection.
• Follow all proper gowning procedures.
• 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.
• Embodies Ajinomoto Bio-Pharma Services cultural values and aligns daily actions with department goals and company culture.

Requirements:

• Associate's degree in a Life Sciences discipline or equivalent training and experience preferred.
• Minimum of Four (4) years of technical experience in Drug Product Finishing Department.
• Minimum of one (1) year of experience in a functional leadership role.
• Ability to pass Project Organizer qualification exam.
• Ability to pass visual acuity exam according to SOP guidelines.
• Ability to pass qualification exams according to SOP guidelines.
• Subject Matter Expert (SME) in all Drug Product Finishing Operations and related GMP requirements.
• Detail oriented with strong written and verbal communication skills.
• Confidence and patience in all communications.
• Demonstrated ability to follow detailed directions in a laboratory/manufacturing environment.
• Ability to work independently, within prescribed guidelines, or as a team member.

The anticipated hourly range for candidates who will work in California is $27.00 - $33.00 USD.

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. Ajinomoto Bio-Pharma Services is a multi-state employer and this salary range may not reflect positions that work in other states. 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 be asked to complete a background check and drug screen as a condition of employment.

For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: FCIHO

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.

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