Pharmaceutical Development Lead Scientist I

Catalent · United States

About Site

Catalents 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 Lead Scientist I to join our team. In this role, you will serve as the technical lead for formulation design and development of oral solid dosage forms. You will design and execute experiments and processes for pharmaceutical formulations and lead clinical trial manufacturing activities. This position ensures compliance with regulatory requirements, good manufacturing practices and standard operating procedures.

Shift: Monday to Friday 8am-5pm
Location: Kansas City, MO
100% Onsite

The Role

• Develop and execute laboratory work plans and schedules for self and junior team members using customer milestones and site performance standards

• Author and approve technical documents such as protocols, test methods, reports, certificates of analysis and operating procedures

• Review technical documents for accuracy, completeness and regulatory compliance

• Train, coach and mentor others on technical, personal development or business issues

• Supervise technical staff, including work assignments and performance management

• Act as technical lead on one or more projects, responsible for project outcomes and customer interaction

• Develop and execute efficiency improvement projects

• Identify and recommend business opportunities on a project-specific basis

• Apply technical and functional knowledge to design experiments, processes and formulations that contribute to the group

• Participate in client interactions during team and ad hoc meetings with minimal supervision

• Maintain high-quality laboratory documentation in accordance with regulatory guidance and site procedures

• Perform all other duties as assigned

The Candidate

Minimum Requirements

• Bachelor's degree in a related life science or physical science field with 11+ years of related work experience preferred

• Expert in data interpretation, applications, instrumentation and theory in at least one area of expertise

• Ability to provide accurate data within regulatory guidance

• Experience evaluating and assessing impact of changes to controlled documents or project scope

• Ability to combine and interpret data from multiple disciplines for a project

• Strong prioritization skills and ability to suggest alternatives or contingencies for technical solutions

• Ability to propose deviations from established procedures based on sound judgment

• Excellent written and verbal communication skills with internal and external customers

• Ability to communicate technical information to non-technical audiences

• Ability to learn and retain technical information

• Leadership development and supervisory skills expected

• Ability to assess new technologies and their impact on offerings

• Lead by example according to company values and culture

• Ability to assess training needs and create development plans for subordinates

• Ability to anticipate and identify unmet customer needs based on technical skills and drug development experience

• Ability to interpret and provide instructions in various formats

• Understanding of regulatory CMC filing package elements and required documentation

• Well organized with ability to multitask

• Ability to work effectively under pressure to meet deadlines

• May publish or present externally

• Physical requirements: Stand, walk, sit, use hands to manipulate and reach with hands and arms for up to 8 hours per day; frequent sitting, standing, walking, reading documents and using a computer screen; able to work with respirator (P100, PAPR, etc.); occasional lifting and moving up to 50 pounds

Preferred Skills & Background

• Masters degree in a related life science or physical science field with 9+ years of related work experience preferred

• Doctorate degree in a related life science or physical science field with 5+ years of related work experience preferred

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.

Visit Catalent Careers to explore career opportunities.

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 DisabilityAccommodations@catalent.com . 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.

Important Security Notice to U.S. Job Seekers:

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