Vikor Scientific Jobs in Usa

Job ID: 410750

Practice area:- IP - Patent - Biochemistry,IP - Patent - Bioengineering,IP - Patent - Biotechnology,IP - Patent - Cellular Technology,IP - Patent - Genetics,IP - Patent - Medicine,IP - Patent - Molecular Biology

Life Sciences Patent Prosecution Associate Attorney (3+ Years) – Biotechnology & Molecular Biology | New York, New York

Keywords:- Patent Associate Attorney, Biotechnology Patent Attorney, Life Sciences Patent Attorney, Patent Prosecution Attorney, Patent Attorney New York, New York legal jobs, Attorney jobs NYC, USPTO registered patent attorney, Law firm patent associate, Partner-track position, lawyer,Biotech patent,pharma patent,life sciences IP,medical device patent,patent prosecution - biotech,USPTO - biology,patent agent - life sciences

A leading intellectual property practice is seeking a Life Sciences Patent Associate Attorney (3+ years experience) to join its growing patent prosecution team in New York, New York. Work with innovative biotechnology and life sciences companies on complex patent portfolio strategy and prosecution.

This law firm was founded over 40 years ago to provide legal services for technology, clean tech sectors, and life sciences companies that are making world-changing innovations. They specialize in offering fast service to keep up with the rapid changes in the technology industry. Their areas of practice include intellectual property, litigation, corporate, and electronic information management. This firm has offices in California, Washington, New York, and Shanghai.

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A prominent intellectual property law practice is seeking a Life Sciences Patent Associate Attorney to join its expanding patent prosecution group in New York, New York. This role focuses on biotechnology and life sciences innovations, supporting cutting-edge companies developing breakthroughs in molecular biology, genetics, cellular technologies, and biotechnology.

Attorneys pursuing New York legal jobs in intellectual property will gain the opportunity to work with emerging technology and life sciences companies while managing sophisticated patent portfolios. The Patent Attorney will assist clients in protecting their intellectual property through strategic patent drafting, prosecution, and counseling.

This partner-track position provides exposure to high-growth industries including biotechnology, medtech, and AI-enabled medical innovations. The role offers hands-on involvement with patent strategy, portfolio development, and intellectual property due diligence in corporate transactions.

This opportunity is actively interviewing candidates seeking advanced New York legal jobs within biotechnology patent law and intellectual property strategy.

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Key Responsibilities

• Manage client relationships and oversee life sciences patent portfolios.

• Draft and prosecute patent applications involving biotechnology, molecular biology, genetics, and cellular technologies.

• Conduct prior art searches and patentability analyses.

• Perform freedom-to-operate analyses for emerging technologies.

• Draft responses to USPTO office actions and manage prosecution strategies.

• Provide intellectual property counseling to biotechnology and life sciences clients.

• Conduct IP due diligence for corporate transactions, financings, and strategic investments.

• Support patent litigation teams with technical analysis when needed.

• Participate in post-grant proceedings before the United States Patent and Trademark Office.

• Mentor junior patent agents and attorneys within the practice.

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Qualifications

• 3+ years of experience as a Patent Associate Attorney within a law firm intellectual property practice.

• Ph.D. or M.S. in a life sciences discipline, such as Molecular Biology, Genetics, Biochemistry, Immunology, Bioengineering, or related field.

• USPTO registration required as a patent practitioner.

• Experience drafting and prosecuting life sciences patent applications.

• Strong scientific understanding of biotechnology and related research fields.

• Ability to collaborate with scientists, inventors, and business teams.

• Excellent legal writing and technical communication skills.

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Education

• Juris Doctor (JD) degree required.

• Ph.D. or M.S. in Cellular & Molecular Biology, Genetics, Biochemistry, Bioengineering, or related field.

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Certifications

• Registered with the United States Patent and Trademark Office (USPTO).

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Skills

• Strong analytical and research capabilities.

• Advanced patent drafting and prosecution skills.

• Excellent written and verbal communication abilities.

• Strong client management and relationship-building skills.

• Leadership ability to mentor junior patent professionals.

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Culture & Firm Appeal

This opportunity is with a well-established intellectual property law firm that focuses on supporting innovative companies across technology, clean technology, and life sciences industries. The firm works with organizations developing transformative technologies and provides legal strategies that help protect and commercialize cutting-edge scientific advancements.

Attorneys benefit from a collaborative and fast-paced environment where legal professionals work closely with inventors, scientists, and technology leaders. The firm emphasizes responsive service, deep technical expertise, and strong client relationships.

Professionals exploring New York legal jobs in intellectual property law will appreciate the firm's strong reputation within the innovation ecosystem and its commitment to supporting groundbreaking technology companies.

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Why This Role Is Unique

• Opportunity to work with biotechnology and life sciences innovators developing breakthrough technologies.

• Exposure to cutting-edge fields including genetics, molecular biology, medtech, and biotechnology.

• Direct involvement in patent portfolio strategy and IP due diligence for corporate transactions.

• Collaborative environment with scientists, inventors, and technology entrepreneurs.

• Clear partner-track position offering long-term career growth.

• Ideal opportunity for attorneys pursuing advanced New York legal jobs in biotechnology patent law.

This position rarely opens at this level and offers the chance to build a specialized practice at the intersection of law, science, and innovation.

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Benefits

• Healthcare and Life Insurance.

• Health Savings Accounts and Flexible Spending Accounts.

• Wellbeing programs.

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Call to Action

Apply now for a confidential discussion with a BCG Attorney Search recruiter.

Explore this elite-level opportunity today.

Submit your resume to learn more about this prestigious role.

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BCG Attorney Search is the industry leader for placing candidates in permanent positions in law firms. Since 2000, our recruiters have placed several thousand attorneys and enjoyed extraordinarily high success rates with our candidates. As a BCG Attorney Search candidate, you have access to more opportunities than any legal placement firm in the United States. We are able to offer the most in-depth insight in the legal recruiting market thanks to our dedicated team of over 150 employees who mercilessly research, study and analyze the legal market. The depth and breadth of our research empowers us to place attorneys at rates that are unparalleled at any placement firm in the United States. Many of our recruiters make 30 to 40 placements per year, while recruiters at competitor firms are likely to make four or five. Unlike other placement firms that can only tell you about openings at major AmLaw firms, we place candidates of all backgrounds in firms of all sizes. While other legal recruiters only represent a narrow band of candidates from top law firms and top law schools, our research, firm contacts, and market insight allow us to place hundreds of candidates each year who do not fit this mold. It is rare that we do not get candidates we represent interviews and offers. No one in the world is better at legal recruiting and placement than BCG Attorney Search.

BCG Attorney Search will confidentially review your application and will not forward your materials to the firm without first discussing the opportunity with you.

Lightwave Logic: (Nasdaq: LWLG) is a publicly traded materials and device development company that is conducting cutting-edge work to commercialize its proprietary organic nonlinear polymers for a variety of electro-optic devices and pushing the state of the art in high-speed fiber-optic telecom and data communications. Our development roadmap is geared to disrupt the industry by introducing organic modulators and related photonic integrated circuits that have superior speed, lower power consumption, and smaller size than current technologies. Our materials and devices are extendable into other applications, including sensors and instrumentation.

Job Description

We are seeking a Process Chemist to join our team in Englewood, CO. The Process Chemist designs, develops, optimizes, and scales chemical processes for the pilot to large-scale manufacturing of intermediate and finished products. The Process Chemist leverages their expertise in ensuring that chemical processes are developed so that the chemical reaction(s) is carried out efficiently, safely, and economically, and are within quality and regulatory compliance. By staying current with scientific literature and collaborating across teams, they drive innovation and efficiency. This role involves supporting IP development, maintaining safety standards, and contributing significantly to the team's success in achieving company goals.

Responsibilities

• Designing, developing, and optimizing chemical processes to improve efficiency, yield, and product quality.
• Conducts laboratory experiments to understand chemical reactions and improve process conditions.
• Ensure that chemical processes comply with regulatory requirements and safety standards.
• Conduct small, pilot, or large-scale manufacturing of intermediates and/or finished products.
• Write/execute technical reports, standard operating procedures, and batch records.
• Ability to work second shift, when needed.
• Remain current on relevant scientific literature.
• Work collaboratively with colleagues across the company; use this collaboration to support the company's goals and improve the chemistry team's output.
• Punctually and thoroughly record all work and data in e-notebook, as well as summarize and report ongoing work to the group regularly.
• Exhibit safety awareness, safe work practices, and common laboratory hygiene, and ensure that all members of the chemistry team abide by the safety policies of the company.
• Other duties and projects as assigned.

Qualifications

• BS/MS in chemistry, chemical engineering, or a related discipline.
• 1-3 years' experience with process development, process optimization, and/or scale-up.
• An understanding and/or familiarity with regulatory compliance in chemical manufacturing.
• Knowledgeable in chemical reaction mechanisms, kinetics, and environmental health and safety practices.
• Ability to use analytical instrumentation (HPLC, GC-MS, DSC, pH meter, etc).
• Ability to operate pilot to large-scale chemistry equipment (chemical reactors, pumps, distillation equipment, etc).
• Strong analytical and troubleshooting skills.
• Ability to conduct literature searches for specific target molecules and reactions; ability to use the literature to design efficient synthetic routes, as well as troubleshoot problematic reactions.
• Thorough understanding of modern analytical and spectroscopic techniques and ability to interpret the corresponding data and spectra.
• Quality-first mindset, which leads to the production of highly pure final products.
• Ability to work independently and efficiently, as well as work across and within groups to support the goals of the company.
• Ability to organize work efficiently, carry out multiple operations in parallel, and successfully complete projects in a timely fashion.
• Excellent written and oral communication skills.

Compensation

The salary range for this role is $75,000-$90,000.

Benefits

LightwaveLogic offers a highly competitive compensation package including stock options, as well as comprehensive benefits including fully paid medical, dental, and vision insurance coverage (employee and family). a generous PTO policy, $500/year(prorated) company contribution to your medical FSA, and a 401K (safeharbor, 4% match).

EEO Statement

Lightwave Logic is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Food Scientist II reports directly to the Research & Technical Development Lead and plays a critical role in advancing technical platforms, ingredient research, and process feasibility for snack and confectionery products. This role is responsible for developing scalable scientific solutions that support the company's innovation pipeline. The position focuses on early-stage formulation science, functionality modeling, and technical risk mitigation prior to commercialization handoff.

The Food Scientist operates within the Technical & Research Team and collaborates closely with the Product Development & Commercialization Team during scale-up and launch readiness phases.

Key Responsibilities:

1. Technical Platform Development

· Support the Research & Technical Development Lead in building and optimizing core technology platforms (e.g., probiotic systems, fiber enriched system, sugar reduction system, hydrocolloid systems, protein enhanced system).

· Conduct ingredient functionality studies to understand structure-function relationships.

· Develop reusable technical frameworks that enable multiple pipeline products.

2. Advanced Formulation Science

· Design and optimize complex formulations for snack and confectionery applications.

· Investigate texture stability, moisture migration, hydrolysis risks, glass transition behavior, and shelf-life quality indicator.

· Conduct structured root cause analysis for technical performance issues.

· Translate scientific findings into scalable formulation strategies.

3. Process Feasibility & Risk Mitigation

· Evaluate processing parameters (e.g., heating time, vacuum, Brix, pH, Aw) to ensure technical robustness.

· Identify potential scalability constraints early in development.

· Support pilot-scale validation and collaborate with commercialization teams as needed.

4. Stability Prediction

· Design preliminary accelerated and real-time stability studies.

· Establish quality benchmarks for texture, moisture, color, and API ingredients.

5. Cross-Functional Collaboration

· Partner with Product Development during transition from research to commercialization.

· Provide technical input to embedded analytical and compliance resources.

· Support supplier technical assessments and ingredient validation.

6. Documentation & Technical Governance

· Maintain accurate and complete formulation documentation in designated systems.

· Develop detailed technical reports and risk assessments for internal review.

Qualifications:

· Master's degree in Food Science, Food Engineering, Chemistry, or related field.

· 2–4+ years of experience in snack and/or confectionery and/or gummy and/or bars of R&D.

· Strong knowledge of hydrocolloids, fiber systems, sugar reduction systems, and moisture control mechanisms.

Job Description

• Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol.
• Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability. -In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
• Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
• Maintains regulatory documents in accordance with SOP and applicable regulations.
• Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research.
• May collaborate with Research Site Leader in the study selection process.
• Additional responsibilities may include working directly with other research bases and/or sponsors.
• Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
• May be responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians.
• May oversee the preparation of orders by physicians to assure that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting.
• Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

Qualifications

• Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred.
• Minimum five years of experience in a clinical or scientific related discipline required.
• SoCRA or ACRP certification preferred.

OR

• Graduate from an accredited program for nursing education (BSN preferred). Minimum 3 years of nursing experience. Experience in clinical research preferred. Current licensure as a registered nurse in state of practice. Current BLCS or ACLS certification required. OCN, SoCRA or ACRP certification preferred.

Title - QC Analyst I (Stability Study Coordinator I)

Duration - 9 Months (Possibility of extension)

Location - Vacaville CA

Summary

With limited supervision, QC Stability Study Coordinator, is responsible for the oversight of stability program management in accordance with cGMP regulations. These duties include execution of trend analysis, documentation review, support of deviations (OOS, OOT, OOE) and other laboratory support activities. In conjunction with Quality Control leadership, the QC Stability Study Coordinator works to meet departmental and organizational goals.

Job Responsibilities

Review data and assess against established acceptance criteria

Perform technical review of peer-generated data

Evaluate data to identify trends and/or establish limits

Identify discrepancies; provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed

Identify and troubleshoot technical problems

Identify gaps in systems and procedures

Receive training

Support the maintenance and compliance of operational areas

Assure and apply GMP throughout operations

Coordinate with customers to support multi-site operational activities

Support internal and external audits and regulatory inspections

Works to meet schedules, timelines, deadlines

Participate in and/or lead group and project teamwork; project and process improvements

Stability Protocol Creation

Stability deviation assessments

Routine Master Data Testing Creation

Routine Master Data Testing Review

Routine and non-routine Out Of Trend linear regression assessments.

Annual Product Quality Reviews (APQRs) - Author assistance develop to authoring

Time Point Approval assistance

Change control of various documents

Data / Data Table requests / annual report requests (non-routine requests) (e.g.,

Client monitor requests)

Actively participate in various stability related projects

Data entry and review

Assist with training coordination

Assist with Perform other duties as requested by managers to support Quality activities

Job Requirements

B.S. /B.A. degree and 1-3 years of experience or an equivalent combination of education and experience. Degrees are preferably in relevant scientific disciplines and experience is in the pharmaceutical or biopharmaceutical industry.

Strong verbal and written communication skills, ability to organize and present information both formally and informally.

Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.

Routinely exercises sound judgment, reasoning and problem solving.

Capable of working under limited supervision and determining own short term priorities.

Essential Functions of the job:

• Review and validate QC data and test records.
• Support investigations related to Out of Specification (OOS), Out of Trend (OOT), and Out of Expectation (OOE) results.
• Ensure compliance with current Good Manufacturing Practices (cGMP) in the laboratory.
• Assist in the technical documentation of investigations and change control assessments to evaluate the impact on product quality, in alignment with FDA/EU regulations, international standards
• Undertake other duties as required.

This position is ideal for candidates who are detail-oriented and committed to quality assurance in the pharmaceutical industry.

Education/Experience Required:

• Bachelor’s Degree or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline. Scientific degree (ideally chemistry, biochemistry, biotechnology or related).
• Minimum 4 years working experience in an FDA-regulated biotechnology or pharmaceutical company is required.
• Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc.
• Strong working knowledge with USP/EP and cGMP/EU GMP.
• Technical writing experience.
• Familiar with instrument and equipment validation.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development
• Self-motivated, with the ability to work proactively using own initiative.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Travel:

• Must be willing to travel approximately 10%.
• Ability to work on a computer for extended periods of time.

Position Summary:

The Associate Director, Quality Control will be responsible for providing strategic, scientific, and operational leadership for the development, qualification, validation, and lifecycle management of analytical methods supporting Upstream Bio’s lead program verekitug. This role will manage and execute GMP quality control (QC) activities directly related to batch release for clinical trial material supply. The leader in this role must assure that quality controls for investigational new drugs (investigational medicinal products) meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations. The Associate Director will report to Senior Director of Analytical and serve as a key partner to Quality, CMC, Regulatory, and cross-functional teams. This individual will provide technical guidance and business acumen to ensure execution of analytical activities for late-stage programs through BLA/MAA submission, approval, and commercial launch.

Key Responsibilities:

• Author, review and approve analytical method procedures/SOPs
• Author, review and approve analytical method transfer/qualification/validation protocols and reports
• Manage external CDMOs and CROs to execute Development and GMP release and stability testing of Drug Substance and Drug Product in a compliant-manner
• Establish and manage reference standard and critical reagent programs
• Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review.
• Perform data verification and audits in order to ensure accuracy of data and analytical processes.
• Ensure compliance with company policies and SOPs as well as global health authority guidelines.
• Create, analyze, verify, and approve QC data such as method validation, release and stability, results, reports, and Certificates of Analysis (COAs).
• Generate, review, and revise specifications, SOPs, and other QC laboratory and testing documentation.
• Lead Out-of-Specification (OOS), Out-of-Trend (OOT), and Deviation investigations related to the QC laboratory and ensure effective corrective and preventive actions (CAPAs) are implemented.

Qualifications:

• Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful.
• Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
• Proficiency with Microsoft software (Word / EXCEL / PowerPoint), Stability software and statistical analysis/trending to support shelf life and labeling is expected.

Knowledge and skills (general and technical) preferred:

• Broad background, strong comprehension, and demonstrated skills in analytical methods development/validation/transfer/similar, reference standards characterization/structural elucidation, and unknown identification.

Education level and/or relevant experience required:

• Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of demonstrated success in leading cross-functional teams and managing projects along with 7+ years relevant analytical experience in a cGMP-compliant pharmaceutical laboratory environment. Any ASQ or other certifications is a plus.

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at .

Compensation

Target Salary Range: $176,400 - $215,600

*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

The role:

The Quality Control Scientist is responsible for execution and oversight of analytical, microbiological, and environmental testing to ensure the safety and quality of cell therapy products and manufacturing operations. The role includes performing GMP testing to support development, donor screening, in-process control, product release, stability, raw material release, and environmental monitoring in accordance with Standard Operating Procedures (SOPs). The QC Scientist serves as a technical resource for analytical methods such as flow cytometry and other cell-based assays, supports assay and equipment qualification, and ensures data integrity and regulatory compliance. Additional responsibilities include authoring or revising procedures, leading continuous improvement initiatives, supporting investigations, contributing to assay development efforts, and train staff as needed.

In the role you will:

• Perform analytical, microbiological, and environmental testing in support of development, donor-screening, in-process control, product release, stability, and raw-material release in accordance with SOPs and GMP requirements.
• Serve as a technical lead for flow-cytometry–based analytical assays, including instrument setup, compensation, gating strategy, data analysis, and troubleshooting.
• Perform and review cell count assays and evaluate data.
• Support method qualification, validation, and transfer for flow cytometry, cell counting, and other analytical assays; ensure accurate, reproducible data generation.
• Conduct environmental and personnel monitoring of controlled areas, including viable air, non-viable particulates, surface, and gowning monitoring.
• Oversee environmental data entry, review, and trend analysis; evaluate results against alert and action levels and support investigations for excursions or adverse trends.
• Execute and review microbiological assays such as sterility, endotoxin (LAL), bioburden, gram staining, growth-promotion, and conductivity/TOC testing.
• Participate in aseptic process simulation (media-fill) runs; provide on-floor QC support during execution and perform subsequent media incubation, inspection, and documentation.
• Sample, test, and document raw-material results and manage disposition.
• Establish and manage relationships with qualified contract laboratories; oversee external testing activities, ensure timely data delivery, review results, and verify accuracy for inclusion in release documentation.
• Compile, verify, and review analytical and microbiological data to support generation of Certificates of Analysis (CoA) for raw materials, intermediates, and drug-product release.
• Oversight of stability testing for intermediates and product to support shelf-life claims and IND submission.
• Author and revise SOPs, test methods, and data records; contribute to laboratory continuous-improvement initiatives.
• Author and revise technical reports and support IND submissions.
• Support and provide technical input to deviation, OOS, and CAPA investigations, ensuring scientific rationale and data integrity.
• Participate in equipment calibration, qualification, and maintenance programs, and assist in implementation of new or revised analytical methods.
• Train staff in flow cytometry, microbiological methods, and GMP documentation practices.
• Maintain compliance with GMP, data-integrity, and safety requirements, ensuring laboratory readiness for internal and regulatory inspections.
• Provide input to QC metrics and data-trending reports for management review.
• Maintain a flexible schedule to accommodate manufacturing and testing demands, including periodic weekend, holiday, or extended-hour work and off-shift coverage as needed.

Qualifications: About you

• Minimum 4-6 years relevant QC experience in a GMP and cleanroom environment, supporting biologics or cell therapy products.
• Demonstrated proficiency in analytical and microbiological testing, including flow cytometry, cell counting, endotoxin, sterility, and environmental monitoring.
• Proven experience supporting method qualification, validation, and transfer activities.
• Strong understanding of data review, good documentation practices, and data integrity.
• Experience conducting and authoring investigations, CAPA development, and laboratory deviation documentation.
• Experience collaborating cross-functionally with Manufacturing, QA, and Analytical Development teams to support GMP operations.
• Requires Bachelor’s degree in a scientific discipline or equivalent combination of education and experience.
• Expertise in flow cytometry, including instrument setup, compensation, gating, and data analysis.
• Experience leading method qualification, transfer, and troubleshooting for analytical and microbiological assays.
• Advanced understanding of aseptic technique and contamination control in GMP cleanroom operations.
• Experience performing or reviewing microbiological assays, including endotoxin (LAL), sterility, bioburden, gram staining and growth-promotion testing.
• Familiarity with environmental and personnel monitoring, including data trending and evaluation against alert/action levels.
• Experience performing or reviewing in-process and release testing for cell-based products.
• Strong knowledge of raw material testing programs, including identity, endotoxin, and bioburden verification.
• Experience coordinating and reviewing external testing with qualified contract laboratories.
• Proficiency in data review, trending, and reporting using paper or electronic based systems.
• Strong understanding and ability for authoring f GMP documentation, investigations, and change controls.
• Ability to train and qualify analysts in technical procedures and GMP compliance.
• Proactive, self-motivated team player who is comfortable working in a dynamic, fast-paced manufacturing setting, working independently with minimal supervision and adapting to changing schedules.

The targeted salary range for this position is $95,000 - $129,600 per year. MiNK is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offered is commensurate with MiNK's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, critical needs of the role, and internal equity.

About the Company

We are seeking an experienced Director, Regulatory CMC to provide strategic and operational leadership for Chemistry, Manufacturing, and Controls regulatory activities across a growing portfolio of development and commercial products. This role will serve as the CMC regulatory subject matter expert, ensuring compliance with global regulatory requirements while supporting efficient development, manufacturing, and lifecycle management. The Director will work closely with Technical Operations, Quality, Manufacturing, and Development teams and will represent CMC Regulatory in interactions with health authorities.

About the Role

This role will serve as the CMC regulatory subject matter expert, ensuring compliance with global regulatory requirements while supporting efficient development, manufacturing, and lifecycle management.

Responsibilities

• Lead the global CMC regulatory strategy for development and marketed products, ensuring alignment with business objectives and regulatory expectations.
• Provide oversight and authorship for CMC sections of regulatory submissions, including INDs/CTAs, BLAs/NDAs, supplements, variations, and annual reports.
• Act as the primary CMC regulatory representative in health authority interactions, including FDA meetings, scientific advice, and regulatory correspondence.
• Support CMC lifecycle management, including comparability assessments, post-approval changes, and regulatory impact evaluations.
• Partner cross-functionally with Technical Operations, Manufacturing, Quality, Analytical Development, and Supply Chain to ensure regulatory compliance and readiness.
• Ensure compliance with ICH guidelines, FDA, EMA, and other global regulatory requirements applicable to CMC activities.
• Contribute to internal governance forums, risk assessments, and regulatory decision-making processes.
• Build and maintain effective relationships with external partners, including CDMOs and regulatory consultants.
• Mentor and develop regulatory staff as appropriate, supporting a culture of regulatory excellence and accountability.

Qualifications

• 10+ years of Regulatory Affairs experience, with significant focus on CMC in pharmaceutical or biotechnology environments.
• Bachelor’s degree in a scientific discipline required; advanced degree (MS, PhD, PharmD) preferred.
• Demonstrated experience supporting IND, BLA, or NDA submissions, including CMC sections.
• Strong working knowledge of global CMC regulatory frameworks (FDA, EMA, ICH).
• Experience collaborating with manufacturing, quality, and technical operations organizations.
• Proven ability to operate effectively in an SME environment, balancing strategic oversight with hands-on execution.
• Excellent written and verbal communication skills, with the ability to clearly convey regulatory requirements and risk.

Required Skills

Strong working knowledge of global CMC regulatory frameworks (FDA, EMA, ICH).

Preferred Skills

Experience collaborating with manufacturing, quality, and technical operations organizations.

Pay range and compensation package

Competitive compensation and comprehensive benefits.

Equal Opportunity Statement

We are committed to diversity and inclusivity.