生物分析科学总监（美国 - 远程，美国）

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
Objectives:
To provide scientific and strategic leadership for all bioanalysis supporting Bausch + Lomb ocular therapeutic programs, from discovery through registration and lifecycle management, across small molecule and large molecule modalities.
Bioanalytical work is currently fully outsourced. The position owns that externalized model end to end — strategy, contract research organization (CRO) selection and governance, and accountability for data quality and regulatory defensibility. Should capital investment be approved, the position is expected to lead the establishment of an internal non-GLP bioanalytical laboratory within approximately the next two years, without interrupting program support.
Responsibilities:
Bioanalytical strategy and program support

• Define and own integrated bioanalytical strategies across small and large molecules, oligonucleotides, biomarkers and anti-drug antibody (ADA) / neutralizing antibody assessment, selecting platforms appropriate to each modality and matrix (LC-MS/MS, ligand-binding assays, hybrid LC-MS, qPCR/ddPCR).

• Represent bioanalysis on cross-functional program teams, translating program questions (dose selection, ocular and systemic exposure, PK/PD, target engagement) into fit-for-purpose analytical plans.

• Establish the tiered assay approach across the portfolio — discovery/exploratory, GLP-validated and GCP-compliant clinical bioanalysis — with clear criteria for the level of validation rigor applied at each stage.

• Author the bioanalytical sections of INDs, IMPDs and NDAs/BLAs, respond to health authority questions, and represent bioanalysis in regulatory interactions and inspections.

Biomarkers and translational analytics
· Lead biomarker assay strategy from exploratory through validated — target engagement, pharmacodynamics, disease progression and patient selection — partnering with Clinical Evidence, Translational Development and Research on fit-for-purpose validation and context of use.
External partner (CRO) governance

• Own the bioanalytical CRO landscape: identify, technically qualify, select and manage vendors across modalities and geographies, and negotiate scope, timelines and budgets with Procurement.

• Provide scientific oversight of outsourced method development, validation and sample analysis — reviewing protocols, reports and data and approving deviations and investigations — and monitor partner performance against quality, turnaround and incurred sample reanalysis metrics consistent with GLP and GCP expectations.

Internal non-GLP laboratory build (anticipated)

• With management, develop the business case, capability roadmap and phased investment plan for the internal laboratory, including make-versus-buy analysis and modality prioritization.

• If approved, lead design and execution: facility fit-out, instrument selection, LIMS and chromatography data system architecture with data integrity and access controls appropriate to a non-GLP research environment, and sample management.

• Recruit, onboard and develop the internal scientific team, and define the enduring hybrid model of internal capability combined with strategic outsourcing.

Leadership, compliance and budget

• Build, lead and mentor a team of scientists; set objectives, manage performance and foster a culture of scientific rigor and data integrity.

• Ensure externally conducted regulated bioanalysis complies with GLP, GCP, ICH M10 and Bausch + Lomb quality, data governance and EHS policies, and that internal non-GLP work operates to documented data-quality standards with non-GLP data clearly identified wherever reported.

• Manage departmental operating and capital budgets and resource planning; maintain awareness of emerging bioanalytical technologies and ocular-specific methodologies.

Requirements:

Education
· Ph.D. in analytical chemistry, biochemistry, pharmaceutical sciences, pharmacology, immunology or a related discipline with 10+ years of industry experience; or M.S. with 14+; or B.S. with 16+.
Required experience

• Demonstrated bioanalytical leadership in pharmaceutical or biotechnology development spanning both small and large molecules / biologics, with hands-on or oversight expertise across LC-MS/MS and ligand-binding platforms.

• Track record in regulated bioanalysis (GLP) supporting IND, NDA and/or BLA submissions, including authorship of regulatory content.

• Substantial experience managing bioanalytical CROs as sponsor-side lead, accountable for outsourced data quality and defensibility.

• People leadership experience hiring and developing scientific staff; deep knowledge of ICH M10, FDA immunogenicity guidance and 21 CFR Part 11.

Strongly preferred

• Demonstrated competence in implementing artificial intelligence (AI) into bioanalytical workflows — for example AI-assisted method development, peak detection and integration,
• or automated data review — with an understanding of the traceability and data integrity obligations that apply when such tools influence reportable results.

• Ocular drug development experience, including familiarity with ocular tissue and fluid matrices and low-volume assay design.

• Experience establishing or expanding a bioanalytical laboratory, including facility design, instrument qualification and laboratory automation.

Competencies

• Strategic, build-oriented mindset comfortable establishing a function with no existing internal infrastructure; comfort with ambiguity, capital planning and matrixed decision-making; strong scientific judgment distinguishing fit-for-purpose from over-engineered approaches.

• Scientific skepticism about where new tools, including AI, add genuine value versus unacceptable risk.

• Excellent influencing and communication skills with non-bioanalytical stakeholders across Clinical, Regulatory, CMC and Quality.

This position may be available in the following location(s): US - Remote
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $175,000.00 and $240,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Bausch + Lomb's Job Offer Fraud Statement.
Our US Benefit Programs: Employee Benefits: Bausch + Lomb..
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Originally posted on Himalayas