Pharmaceutical Chemist III (Injectable Formulation Development)

  • Full Time
  • San Diego, CA
  • Posted 2 weeks ago
  • March 31, 2021

About the job
Position Overview

Job Description

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Catalent Pharma Solutions is actively hiring for a Pharmaceutical Chemist III in San Diego in our Injectables group. An individual at the level of Chemist III will be expected to take responsibility for the completion of projects under minimal supervision.

The individual will be expected to develop timelines and plan series of experiments as required by service agreements and then coordinate and possibly delegate responsibilities to meet Client’s expectations. The individual must have a fundamental understanding of ICH guidelines for the chemistry, manufacturing and controls (CMC) of drug products. The individual may be required to assist in the creation and/or revision of company SOPs and to participate in continuous improvement projects. The Chemist III will be increasingly sought for training and mentoring of other colleagues, and may supervise a lab assistant. All duties will be performed in compliance with company standard operating procedures (SOPs) and GMP regulations, as appropriate.be expected to communicate the status of projects to management and clients, and manage project timelines.

The individual should be able to propose solutions or approaches to investigate most scientific problems. The individual may be required to assist in the creation and/or revision of company SOPs. The Chemist II will be increasingly sought for training and mentoring of other colleagues. All duties will be performed in compliance with company standard operating procedures (SOPs) and GMP regulations, as appropriate.

Role (daily Responsibilities)
Conduct and/or supervise the execution of analytical and formulation studies for injectable drug candidates
Selects and evaluates container/closure systems and storage conditions under supervision.
Develop, optimize or troubleshoot stability-indicating HPLC analytical methods when appropriate
Develop lyophilization cycles for injectable products
Prepare update documents and technical reports for clients
Demonstrates competency in GMP and IND enabling formulation strategies
Complex experimental design and execution will be performed independently with minimal supervisor assistance.
Develop strategic experimental plans and timelines
Exercise technical discretion and critical thinking in the design, execution and interpretation of experiments independently with minimal supervisor assistance. Data interpretation should be conducted with guidance on complex issues only.
Clear and accurate record keeping in laboratory notebooks and secondary review of other colleagues’ work for scientific accuracy and compliance
Individuals will contribute to discussions with clients and peers on strategic matters.
Primary responsibility for individual client projects with strategic support from supervisor. Lead discussions with clients on technical topics relating to their project. Supervisor may not need to attend all meetings.
Individuals should have a good general foundation of scientific principles, chemistry concepts, and be proficient in core analytical scientific techniques, GMPs, and technical writing.
Maintain a high level of professional expertise through familiarity with scientific literature
Comply with good housekeeping and safety practices
Supervisory duties for a laboratory assistant

The Candidate (requirements)
4 year degree in a physical, chemical, biological, or pharmaceutical science required
BS with 3 to 5 years of experience in injectable development
MS with 2 to 4 years of experience in injectable development
PhD with 0 to 2 years of experience in injectable development
Previous formulation, analytical, and manufacturing experience strongly preferred.
Knowledgeable in cGMPs, IND-enabling formulation strategies, USP/EP compendial testing, and ICH guidelines.
Proven analytical and creative problem-solving skills.
Effective communication and time management skills, with the ability to work under pressure.
Strong organizational skills and high attention to detail.

Catalent’s standard leadership competencies that are used to interview and for Performance & Development
Leads with Integrity and Respect
Delivers Results
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Champions Change
Engages and Inspires
Coaches and Develops

Position Benefits
Potential for career growth within an expanding team
Defined career path and annual performance review and feedback process
Medical, Dental, Vision insurance and 401k are all offered from Day One of employment
19 days of paid time off (PTO) and generous paid holidays annually

About Catalent San Diego

Catalent San Diego, Inc. (Formerly Pharmatek Laboratories, Inc.) is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. Catalent San Diego focuses on bringing client drug compounds from discovery to the clinic with services that include analytical development, preformulation testing, formulation development, GMP manufacturing and stability storage and testing. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. We provide a generous benefits package, on-site gym and fitness programs, team sports, activities and competitive compensation.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.
Visit www.catalent.com/careers to explore career opportunities.

C atalent 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, protected veteran status, sexual orientation or gender identity. 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, and confirming your request for an accommodation and include the job number, title and location to [email protected] . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Tagged as: project management biotech pharmaceutical scientist

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