Pharmaceutical Development Senior Associate Scientist II

RiseMe; Kansas; On-site; USD 85,000 - 120,000; Full time

Job summary

Catalent's Kansas City facility is seeking a Pharmaceutical Development Senior Associate Scientist II to support formulation design and development of oral solid drug products and to train others in clinical trial manufacturing operations using sound pharmaceutical principles.

You will ensure all work complies with regulatory requirements, GMPs and site SOPs, and will perform laboratory testing, documentation and routine procedures in a GMP setting.

Qualifications

• Bachelor's degree in a related life or physical science field with 4+ years of related work experience.
• Master’s degree in a related life science or physical science field with 2+ years of related work experience.
• Strong knowledge of the principles and concepts of pharmaceutics.
• Ability to apply mathematical and scientific reasoning.
• Excellent written and verbal communication skills with internal and external customers.
• Understanding of current Good Manufacturing Practices and ability to work in GMP space with supervision.

Responsibilities

• Execute laboratory work plans and schedules with input from supervisor or senior team member.
• Draft technical documents such as batch records, technical reports and standard operating procedures with limited guidance.
• Train others on procedures and laboratory techniques.
• Execute efficiency improvement projects with limited guidance.
• Perform parallel review of manufacturing documentation and may qualify to perform technical review for accuracy, thoroughness and regulatory compliance.
• Maintain high-quality laboratory documentation in accordance with regulatory guidance and site procedures.
• Perform physical testing as needed, including bulk/tap density, flow analysis, and sieve analysis.
• Execute procedures or methods of moderate complexity with high quality.
• Conduct work in GMP area under minimal supervision.
• Perform all other duties as assigned.

Skills

Pharmaceutics principles

Mathematical reasoning

Communication skills

GMP compliance understanding

Laboratory technique troubleshooting

Education

Bachelor's degree in life science or physical science with 4+ years experience

Master’s degree in life science or physical science with 2+ years experience

Tools

Laboratory instruments familiarity

Documentation skills (batch records, reports)

Job description

About Site

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.

Position Summary

We have an opportunity for a Pharmaceutical Development Senior Associate Scientist II to join our team. In this role, you will support formulation design and development of oral solid drug products. You will train others in clinical trial manufacturing operations using sound pharmaceutical principles. You will ensure all work complies with regulatory requirements, good manufacturing practices and standard operating procedures.

Shift: M-Th or Tues-Fri 12pm-10:30pm
Location: Kansas City, MO
100% Onsite

The Role

• Execute laboratory work plans and schedules with input from supervisor or senior team member
• Draft technical documents such as batch records, technical reports and standard operating procedures with limited guidance
• Train others on procedures and laboratory techniques
• Execute efficiency improvement projects with limited guidance
• Perform parallel review of manufacturing documentation and may qualify to perform technical review for accuracy, thoroughness and regulatory compliance
• Maintain high-quality laboratory documentation in accordance with regulatory guidance and site procedures
• Perform physical testing as needed, including bulk/tap density, flow analysis (FT4) and sieve analysis
• Execute procedures or methods of moderate complexity with high quality
• Conduct work in GMP area under minimal supervision
• Perform all other duties as assigned

The Candidate

Minimum Requirements

• Bachelor's degree in a related life science or physical science field with 4+ years of related work experience preferred, or a Master’s degree in a related life science or physical science field with 2+ years of related work experience preferred
• Strong knowledge of the principles and concepts of pharmaceutics
• Ability to apply mathematical and scientific reasoning
• Advanced understanding of equipment and instrument operations and troubleshooting skills in multiple techniques
• Excellent written and verbal communication skills with internal and external customers
• Understanding of current Good Manufacturing Practices and ability to work in GMP space with supervision

Preferred Skills & Background

• Not applicable

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive paid time off plus 8 paid holidays
• Community engagement and green initiatives
• Medical, dental and vision benefits effective day one of employment
• Tuition reimbursement

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.

personal initiative. dynamic pace. meaningful work.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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 [e-mail]. 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.

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.