Senior Scientist - Biopharmaceutical Services

Pace Life Sciences provides a full suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries from our network of CDMO sites, GMP analytical testing laboratories, and manufacturing support service centers. Our experienced, highly trained industry experts and our investment in state-of-the-art development and manufacturing facilities emphasize our commitment to efficiently advancing client programs through the clinic to commercialization. We share a common goal to bring real value to people, healthcare professionals, and health businesses worldwide. Driven by our commitment to improving our health, we deliver services that offer hope and a better, safer, healthier life for everyone.

Summary:

The Senior Scientist fills a critical technical role in the Biopharmaceutical Services department that is responsible for providing or overseeing the transfer, development, and qualification/validation of analytical test methods and subsequent release and stability testing of biopharmaceuticals, including therapeutic proteins, synthetic peptides, oligonucleotides, and antibody-drug conjugates spanning Pre-Investigational New Drug through Phase III programs.

Essential Functions:

A successful candidate will perform the following major duties and requirements listed below. Job-related duties other than those in this document may be needed as we continue to expand our offering and increase the number of patients we ultimately support.

• Guarantees integrity in all aspects of the analytical support provided to our clients
• Ensures team members in Biopharmaceutical Services consistently feel appreciated and valued
• Continually builds positive, strong relationships with our customers
• Defines prioritizes and honors all internal and external commitments
• Safely generates high-quality data in a cGMP-regulated laboratory environment according to a defined plan and delivered on time within a signed scope of work
• Proactively executes the transfer, development, and qualification/validation of analytical test methods and subsequent release and stability testing of biopharmaceuticals
• Serves as a subject matter expert and/or technical lead in multiple areas of biopharmaceutical testing for current and prospective clients
• Routinely provides creative and flexible solutions in response to unexpected changes in demand within a fast-paced environment
• Leads or contributes to opportunities directed toward departmental stabilization, promoting collaborative teamwork, pursuing offering expansion, and realization of potential resources
• Continuously drives strategic department improvement initiatives concerning people, equipment, practices, procedures, and policies via the utilization of lean six sigma tools
• Provides team members with empowerment and training to support the continual development

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements below represent the required knowledge, skill, and/or ability.

Education and experience:

• A Bachelor's degree in an applicable scientific discipline and 10 years of industry-related experience or equivalent
• A Master's degree in an applicable scientific discipline and 8 years of industry-related experience or equivalent
• A Ph.D. in an applicable scientific discipline and 4 years of industry-related experience or equivalent

Required Knowledge and Skills:

• A recognized subject matter expert in multiple techniques utilized in biopharmaceutical testing that may include HPLC/UPLC, CE-SDS, icIEF, SDS-PAGE, qPCR, ELISA, and LC-MS
• A proven track record of successfully completing transfer, development, and phase-appropriate qualification/validation of analytical test methods in a cGMP environment
• Experience with testing a broad range of biopharmaceuticals that may include therapeutic proteins, synthetic peptides, oligonucleotides, and antibody-drug conjugates
• A proven history of effective communication (verbal, written, and visual) with technical and non-technical internal team members, cross-functional partners, and external clients
• Experience with the broad range of regulatory guidance documents applicable to Pre-Investigational New Drugs through Phase III programs for biotherapeutics
• The ability to thrive with a high degree of acumen and resolve complex problems as a leader or individual contributor in a fast-paced, collaborative environment across site boundaries
• Previous technical program management experience that includes the administration and oversite of associated practices, procedures, and policies is preferred.
• Previous success guiding the acquisition and implementation of technical solutions and/or advancements requiring capital investment is preferred.

Physical/Mental Requirements:

The physical demands described herein are representative of those that an employee must meet to perform the essential functions of the job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.

Working Environment:

Work is performed in a lab and office setting. Work is subject to chemicals, fumes, gasses, noxious odors, and related items in a lab setting.

This role is working the first shift Monday through Friday. From time to time, this position may need to come in early, stay late, and occasionally weekend work to meet clients' needs.

OFCCP Statement

Pace Analytical Life Sciences is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veteran, individuals with disabilities, sexual orientation, or gender identity.

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