With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The Manufacturing Supervisor will work alongside the manufacturing team on the production floor while providing daily supervision, guidance and support to the manufacturing associate team, ensuring efficiency and adherence to the manufacturing schedule.
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Responsibilities- Sets example and enforces all safety, quality, environmental, operational and personnel policies.
- Maintain accurate production logs, batch records and other relevant documentation.
- Exercises job knowledge as SME to independently and provide on-the-job training where necessary.
- Enforce SOPs and quality standards.
- Ensure all activities comply with FDA, GMP, and other regulatory requirements.
- Planning and adjusting the production schedule as needed to meet deadlines.
- Lead and guide associates through process and workflow improvement and MS&T initiatives.
- Lead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging.
- Represent departmental activities as needed, including project teams and task forces.
- Review GMP records for completeness, accuracy, and compliance daily in conformance with regulatory requirements.
- Draft, revise and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation.
- Identify and initiate deviations, assist in assessing product quality impact, and assisting with proposals for Corrective and Preventative Actions (CAPA).
- Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
- Operate to the highest ethical and moral standards.
- Adjust to a flexible work schedule including weekend work, as needed.
- Perform additional duties as assigned.
Qualifications- BA/BS degree that included laboratory work in a chemistry or biology preferred.
- At least 4+ years of cell culture experience in a cGMP pharmaceutical/biotech environment role.
- Strong leadership, organizational, communication skills.
- Demonstrate clear understanding of cGMP.
- Skilled in aseptic handling, including BSC operations to maintain the integrity of open cell culture operations.
- Skilled with using single-use technologies, such as tube welding, tube sealing, and disposable systems.
- Strong technical and mechanical aptitude in bioprocessing.
- Knowledge of mammalian cell culture processes and skilled in operating bioreactors.
- Experience leading, training, and coaching peers.
- Computer proficiency.
- A proven ability to confidently compute basic arithmetic operations.
Physical Requirements- Ability to sit or stand for extended periods of time.
- Frequently lift and or move objects at least 50 pounds in weight.
- Stand/walk during the entire length of shift.
- Use arms, hands and fingers to handle, feel or reach.
- Ability to climb, balance, stoop, kneel, crouch, or crawl.
- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
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$100,000 - $120,000 a year
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FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.