Associate Scientist II
Catalent Pharma Solutions
Summary
We have an opportunity for an Associate Scientist II to join our team in the Biologics Department. The role involves providing and reporting data required by project contracts, supporting regulatory submissions, release and stability testing, and development projects. This position offers the chance to work with advanced analytical techniques and contribute to the success of large molecule therapeutics.
Job description
Position Summary
We have an opportunity for an Associate Scientist II to join our team in the Biologics Department. The role involves providing and reporting data required by project contracts, supporting regulatory submissions, release and stability testing, and development projects. This position offers the chance to work with advanced analytical techniques and contribute to the success of large molecule therapeutics.
The Role
- Execute laboratory work plans and schedules for large molecule therapeutics with input from supervisors or senior team members.
- Handle sample types including in-process, release, or stability testing.
- Perform analytical techniques such as HPLC/UPLC (SEC, IEX, RP-HPLC, HIC, peptide mapping, glycan analysis), Karl Fischer, compendia assays (appearance, pH), UV-Vis, Solo-VPE, Nano Drop, and aggregation techniques (MFI, AUC, SEC-MALS).
- Conduct method validation or transfer activities under direction.
- Perform activities under current Good Manufacturing Practices (cGMP) as appropriate.
- Draft technical documents such as methods or certificates of analysis.
- Review laboratory documentation for accuracy, thoroughness, and regulatory compliance.
- Train others on laboratory techniques.
- Assist in efficiency improvement projects with guidance.
- Perform other duties as assigned.
The Candidate
- Bachelor’s degree in life sciences such as chemistry, biochemistry, biology, or a closely related physical science.
- 0–3 years of relevant experience preferred or based on performance at Catalent.
- Maintain high-quality laboratory documentation in accordance with regulatory guidance and site standard operating procedures.
- Ability to learn and retain technical information effectively.
- Proactively address work issues individually and within a team.
- Execute moderately complex procedures or methods with high quality.
- Interpret written, oral, diagram, or schedule instructions accurately.
- Demonstrate mathematical and scientific reasoning ability.
- Basic understanding of instrument operations and troubleshooting across multiple techniques.
- Identify and interpret out-of-specification data appropriately.
- Strong written and verbal communication skills with internal and external customers.
- Lead by example in alignment with Catalent’s values and culture.
- Demonstrate leadership capabilities in a matrix environment.
- Recognize unmet needs within the department.
- Focus on personal time management and efficiency.
- Well organized with the ability to multitask and meet deadlines under pressure.
- Physical ability to walk, sit, and stand during an 8-hour day; use hands to handle or feel; reach with hands and arms at or above shoulder height and below waist height; climb, balance, stoop, kneel, crouch, or crawl; talk, hear, smell, and lift up to 40 pounds.
- Specific vision requirements include reading written documents, visual inspection of materials, and frequent use of a computer monitor.
- May require the use of a respirator.
Requirements
- Bachelor’s degree in life sciences such as chemistry, biochemistry, biology, or a closely related physical science.
- 0–3 years of relevant experience preferred or based on performance at Catalent.
- Maintain high-quality laboratory documentation in accordance with regulatory guidance and site standard operating procedures.
- Ability to learn and retain technical information effectively.
- Proactively address work issues individually and within a team.
- Execute moderately complex procedures or methods with high quality.
- Interpret written, oral, diagram, or schedule instructions accurately.
- Demonstrate mathematical and scientific reasoning ability.
- Basic understanding of instrument operations and troubleshooting across multiple techniques.
- Identify and interpret out-of-specification data appropriately.
- Strong written and verbal communication skills with internal and external customers.
- Lead by example in alignment with Catalent’s values and culture.
- Demonstrate leadership capabilities in a matrix environment.
- Recognize unmet needs within the department.
- Focus on personal time management and efficiency.
- Well organized with the ability to multitask and meet deadlines under pressure.
- Physical ability to walk, sit, and stand during an 8-hour day; use hands to handle or feel; reach with hands and arms at or above shoulder height and below waist height; climb, balance, stoop, kneel, crouch, or crawl; talk, hear, smell, and lift up to 40 pounds.
- Specific vision requirements include reading written documents, visual inspection of materials, and frequent use of a computer monitor.
- May require the use of a respirator.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Paid time off
- Paid holidays
- Tuition reimbursement
Company overview
Catalent Pharma Solutions, now known as Catalent, Inc., is a leading global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida. Founded in 2007 as a spin-off from Cardinal Health's pharmaceutical technologies segment, the company has grown into a major player in the pharmaceutical services industry. Catalent provides comprehensive drug development and manufacturing solutions including drug delivery technologies, formulation development, analytical testing, clinical and commercial manufacturing, clinical packaging, and supply chain services. The company operates over 50 facilities across four continents and has supported more than half of all FDA-approved products over the past decade. With approximately 16,900 employees, Catalent produces over 70 billion doses annually for more than 8,000 products, serving major pharmaceutical companies like Pfizer, Moderna, Novo Nordisk, and Bristol-Myers Squibb. In 2024, the company was acquired by Novo Holdings A/S for $16.5 billion, further strengthening its position in the global pharmaceutical manufacturing landscape.