Catalent Pharma Solutions 2nd Shift Associate, cGMP Biomanufacturing (Sun-Wed) in Madison, Wisconsin

Job Description

Catalent Biologics is a fast growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art Biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.

I. Position Overview:

The cGMP Biomanufacturing group is responsible for current Good Manufacturing Practices (cGMP) production activities, including Master/Working Cell Bank production, Upstream cell culture, Downstream protein/mRNA purification, and/or Fill/Finish.

This is an entry level position and is the starting point to acquire skills and training required for a cGMP Biomanufacturing environment. The position is expected to follow detailed instructions and established procedures with frequent supervision.

II. Specific Duties, Activities, and Responsibilities:

  • Performs aseptic techniques within in a clean room environment.

  • Executes and properly documents cGMP Biomanufacturing activities.

  • Operates cGMP Biomanufacturing equipment, including pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH).

  • Maintains effectiveness of Quality system.

  • Stages raw materials/components for use within cGMP Biomanufacturing.

  • Performs general cleanroom housekeeping, including room and equipment cleaning(s), disposal of trash and recyclables, and adherence to 5S standards.

  • Accurately completes routine and preventive maintenance on designated equipment.

  • Supports Biomanufacturing staff with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA) revisions, deviation investigations, and change control/protocol execution, by established due dates.

  • Actively participates in team meetings and/or training sessions.

  • Performs media/solution preparation.

  • Works scheduled shift and other off-shift coverage as required.

  • Other duties as assigned, including:

  • Downstream/mRNA

  • Operates assigned Biomanufacturing equipment, including chromatography skids, Normal Flow Filtration and Tangential Flow Filtration skids.

  • Performs column, membrane adsorption and size-exclusion chromatography, including viral reduction and filtration steps.

  • Performs Bulk Drug Substance filling operations.

  • Performs routine protein purification analytics, including protein concentration, pH and conductivity.

  • Solution Preparation

  • Operates assigned Biomanufacturing equipment, including fume hood or equivalent.

  • Weighs and dispenses chemicals and components.

  • Kits and stages materials for solution preparation.

  • Fill/Finish

  • Operates assigned Biomanufacturing equipment, including dosing pump and pneumatic crimper/capper.

  • Performs vial and media filling operations, including inspection, labeling and packaging.

III. Position Requirements:

Education:

  • B.S./B.A. in Biotechnology, or related field with no previous industry laboratory experience; or

  • Associates Degree/Certificate/Diploma with a minimum of 2 years’ experience in related laboratory work.

  • High School Diploma or equivalent with a minimum of 3 years’ experience in related laboratory work.

Experience:

  • Preferred:

  • Clean room, aseptic technique, and/or general lab equipment experience.

  • cGMP, Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) knowledge.

  • Following standard operating procedures (SOP).

IV. Dimensions of Position:

Scope of Responsibility:

Direct Reports: N/A

Total Site Staff (includes directs): N/A

V. Physical, Safety and Behavioral Requirements of the Position:

Technical Requirements:

  • Ability to maintain batch records and/or laboratory notebook and complete all laboratory documentation in clear and accurate language and according to SOP.

  • Ability to attend training and apply learning on routine operation, maintenance and theory or laboratory instrumentation, SOPs, and regulatory guidelines.

  • Ability to use Excel, Word, and other office systems.

  • Ability to add, subtract, multiply, divide and to record, balance, and check results for accuracy.

  • Ability to peer review data to ensure data is well organized with complete documentation.

  • Ability to work within ISO 6/7/8 clean room environments.

Behavioral Requirements:

  • Ability to see and hear, read and write clear English.

  • Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writing.

  • Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner.

  • Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time

  • Ability to cooperate with coworkers within an organized team environment or work alone.

  • Detail oriented with ability to work effectively under high pressure with multiple deadlines.

  • Ability to effectively carry out and implement change.

  • Ability to put aside personal opinions and focus on business needs, department needs or group needs.

Safety and Environmental Requirements:

  • Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.

  • Occasional stooping, kneeling, crouching, bending, carrying, grasping.

  • Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.

  • Must comply with EHS responsibilities for the position.

  • Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures must be followed to minimize exposure, including proper use of PPE (personal protective equipment) and clean room gowning.

  • Working conditions will be Heating Ventilation and Air Conditioned controlled.

Business Environment:

  • Fast-paced

  • Performance driven

  • Customer focused

  • Collaborative and inclusive

  • Team player

Catalent Values and Competencies:

Catalent Values
  • Dedicated to our customers

  • Relentlessly pursue innovation and continuous improvement

  • Strive for excellence and speed, every day

  • Driven by a passion for growth and developing our people

  • Commit to uncompromising integrity, personal accountability, and respect for each other

    Competencies
  • Passion for Excellence

  • Engages & Inspires

  • Invests in Customers’ Success

  • Delivers Innovative Solutions

  • Builds Collaboration & Teamwork

  • Drives Growth

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.