Job Description

Recruiters please do not contact this job poster. Please be advised: Solvias does not accept unsolicited resumes or services from third-party recruitment agencies. In the event, a recruiter or agency submits a resume or candidate without an agreement we shall explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to Company employees, shall be deemed the property of the Company.

Solvias is an internationally recognized provider of integrated solutions in contract analytical research, development, and manufacturing. The company offers a broad spectrum of services and solutions in the Pharmaceutical, Biotech, Medical Device, Cell and Gene Therapy (CGT), and Cosmetic industries. With headquarters near Basel, Switzerland, about 800 highly qualified employees take pride in putting science at the heart of serving customers to bring safer and better products to market faster.

Position Overview

Located at our Large Molecule headquarters in RTP, North Carolina the Director, Cell-Based Bioassay will be responsible for overall management of all cell-based Bioassay laboratory functions and manage experienced bioanalytical scientists supporting needs across our cell-based bioassay portfolio. Additionally, this position will work closely with quality leads to ensure assays meet regulatory expectations or the intended context of use. The Director, Cell-Based Bioassay will be responsible for regulated bioanalysis review, approvals of bioanalytical data and reports, and contribution to regulatory submission(s). As a Subject Matter Expert, this position will be responsible for enhancing the reputation for scientific excellence by speaking publicly at internal and external meetings.

Critical Performance Areas

• Responsible for overall management of laboratory personnel and fiduciary obligations to clients.
• Manage and lead a scientific team to develop, optimize, qualify, validate, and transfer (non)regulated cell-based potency and functional assays for biologics.
• Broad knowledge of current and future trends in the Biologics and Advanced Therapy Medicinal Products (ATMP) marketplace in relation to contract laboratory management.
• Ability to simultaneously manage several complex programs and communicate effectively with clients.
• Display strong leadership skills to direct staff and ensure strict adherence to appropriate regulatory requirements, including SOP’s, US FDA and US EPA Good Laboratory Practices (GLP) and US FDA current Good Manufacturing Practices (cGMP).
• Responsible for proposal, protocol, client management, contract development and evaluation.
• Represent the function in regulatory submissions, inspections, and audits.
• Develop and manage departmental budgets, ensuring alignment with organizational goals and efficient resource allocation.
• Contribute to financial planning and strategic decision-making to support business growth and operational excellence.

Essential Job Functions

• Advanced knowledge of cell-based bioassays used in CMC characterization, principles , and techniques as well as methods development, validations, and regulatory compliance pertinent to the work being completed.
• Solid knowledge of financial workings of a contract laboratory.
• Accurately project capacity management including staff and additional resource needs in a timely and effective manner.
• Interpret data, provide scientific insight, drive innovation in assay technologies and implement best practices for assay robustness, automation, and data analysis.

Requirements

• B.S. in Cell Biology, Immunology, Biochemistry or related field with 20+ years of relevant industry experience; or MS in Cell Biology, Immunology, Biochemistry or related field with 15+ years of relevant industry experience; or Ph.D. in Cell Biology, Immunology, Biochemistry or related field with 10+ years of relevant industry experience.
• Experience in Pharmaceutical, CDMO, or cGMP required.
• Demonstrated leadership experience managing scientific teams and complex programs in a CRO, CDMO, cGMP, or biopharmaceutical environment required.
• Proven record of successful client consultation and project management.
• Proven track record in developing and validating cell-based assays for biologics, including monoclonal antibodies (mAbs), cell and gene therapies (CGT), or vaccines.

Other Desired Skills/Abilities

• Site or laboratory startup experience a plus.
• Excellent written and verbal communication skills.
• Strong financial aptitude.

NOTE: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

Disclaimer: Solvias North America does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.

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