Our vision is to transform product design, development, and characterization to enable delivery of new medicines to patients. In this role, you will lead analytical strategy and delivery for oral solid dosage (OSD) forms and, as needed, inhaled and/or parenteral products from early development through clinical supply and toward commercialization.

As the analytical project/skill lead, you will partner across formulation, engineering, biopharmaceutics, manufacturing, QA and Regulatory to deliver robust methods, efficient control strategies, and submission-ready documentation. You will also help establish and optimize OSD laboratory capabilities at the Durham site, champion laboratory automation, and encourage adoption of modern data analytics and AI/ML tools to accelerate development and interpretation.

We work, on average, a minimum of three days per week from the office. We balance the expectation of being in the office while respecting individual flexibility.

Responsibilities include, but are not limited to:

• Project leadership: Act as analytical skill lead to secure major drug product deliveries, applying a risk-based, flexible approach to prioritization, resources, and timelines across modalities and dosage forms; integrate analytical plans with global teams and external partners/CMOs.

• Analytical strategy & control: Define and own a phase-appropriate analytical control strategy aligned with CMC expectations across clinical phases; harmonize methods and embed lifecycle management to ensure robust, efficient control.

• Method development & validation: Design, develop, validate, transfer, and lifecycle manage analytical methods for OSD (e.g., HPLC/UPLC, LC–MS, dissolution, impurity profiling, stability-indicating capability); establish scientifically supported system suitability, specifications, and fit-for-purpose sample preparation; ensure readiness for GMP execution with clear documentation and analyst guidance. Support inhaled and/or parenteral methods as needed.

• Characterization & performance: Lead drug product characterization, comparability, and stability programs; direct forced degradation studies; for inhaled products where required, support aerodynamic performance assessments (e.g., impactor analysis).

• CMC & regulatory: Author and review analytical CMC content for IND/IMPD/NDA/MAA; prepare validation reports, method transfer documents, and specifications; lead responses to regulatory queries and support shelf life assignment with appropriate statistics.

• Cross-functional collaboration: Work closely with formulators, engineers, supply and manufacturing sites, QA, Regulatory, and external partners/CMOs to integrate analytical deliverables into project plans and clinical manufacturing.

• Durham lab capability & technology: Champion laboratory automation for sample preparation, method execution, and data analysis under GxP control.

• Problem-solving: Lead complex investigations, root cause analyses, and data integrity assessments; apply structured problem-solving (e.g., Six Sigma) and statistics to drive timely resolution and preventive actions.

• Digital, data & innovation: Apply DoE and statistics for method robustness and understanding; use ELN/CDS and statistical tools; promote AI/ML, chemometrics, and predictive analytics to enhance interpretation, specification setting, and development speed; enable learning and standardization across projects; chip in to patenting and/or publishing.

• Quality & governance: Ensure GxP compliance where applicable, data integrity, rigorous study design, and clear communication to governance bodies.

Minimum Qualifications:

• Bachelor’s (12+ years), Master’s (6+ years), or PhD (or equivalent experience) in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related field.

• Significant experience in pharmaceutical analytical science with current knowledge of regulatory CMC requirements for clinical and/or marketing applications.

• Demonstrated experience in analytical development for oral solid dosage forms; additional experience with inhaled and/or parenteral products preferred.

• Consistent record leading teams and/or scientific projects within a global organization and with external partners/CMOs; ability to influence cross-functional strategies.

• Strong proficiency with chromatographic techniques (HPLC/UPLC; LC–MS), dissolution, and complementary methodologies; for inhaled products, familiarity with aerosol performance characterization is a plus.

• Hands-on experience in method development (including use of supporting software), validation, transfer, and lifecycle management under ICH guidelines and phase-appropriate frameworks.

• Experience authoring analytical CMC content for submissions and responding to regulatory queries across clinical development.

• Experience working in a GMP/GxP environment; familiarity with instrument/equipment qualification, calibration, and maintenance expectations.

• Excellent communication, customer management, and influencing skills; ability to operate confidently and collaboratively across global, cross-disciplinary environments.

• Demonstrated ability to troubleshoot technical challenges and drive data-driven decisions.

• Fundamental digital and data capability relevant to analytical development, including:

• Proficiency with multivariate experimental design and basic DoE concepts for method and process understanding

• Working knowledge of statistics for analytical science (e.g., regression, ANOVA, capability/variation analysis, stability trending, OOS/OOT investigation)

• Practical use of ELN/CDS and statistical software (e.g., JMP or Minitab) for data analysis and reporting

Preferred Qualifications:

• Strategic chromatographic and separation science leadership: define orthogonal method suites (e.g., RP, HILIC, ion exchange, SEC, SFC, CE) to secure impurity resolution and stability-indicating capability; apply LC–MS(/MS) for structure confirmation and quantitation; use multidimensional LC and targeted DoE to accelerate development and set robust specifications; harmonize methods across sites with clear comparability criteria; embed lifecycle management and coach teams through complex separations (e.g., peptides, oligonucleotides, challenging matrices).

• OSD focus: Support with establishing, equipping, and optimizing OSD test equipment and processes at the Durham site.

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As a Corporate Legal Specialist, you will manage the full lifecycle of U.S. entity administration, including formations, qualifications, dissolutions, annual reports, assist with franchise tax filings, and obtain certificates of good standing, certified copies and coordinate notarizations and apostilles.

You will maintain accurate and up-to-date corporate records for Anthropic PBC and its subsidiaries, including minute books, stock ledgers, org. charts, officer/director lists, and entity management databases.

You will assist with new entity incorporations and structuring, including domestic and international subsidiary formations and post-incorporation operational matters (i.e. opening of bank accounts, obtaining tax registrations, injection of capitalizations, etc.), in coordination with outside counsel and cross functional teams.

You will support Anthropic's international entities with board and shareholder meetings, corporate maintenance, local filings, KYC requests, apostilles, legalizations, and cross-border documentation.

You will coordinate signatory authority, powers of attorney, and corporate approvals for commercial, financing, real estate, and employment matters.

You will respond to diligence requests in connection with financings, acquisitions, audits, commercial transactions, and regulatory inquiries.

You will be able to assist with in-house notarizations (if licensed as a State of California Notary Public).

You will own and continuously improve entity management tools, workflows, and internal knowledge resources; help build scalable processes as Anthropic's footprint grows.

You will partner with cross-functional teams on matters including equity administration, tax, compliance, insurance, and trademark/IP record maintenance.

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This is a hands-on role involving solution mixing, reactor operation, particulate washing and drying, filtration, liquid waste handling, and general materials processing.

Operators will be cross-trained across multiple systems and will support operations in Standard Nuclear's Oak Ridge facilities to ensure consistent production output.

This position requires mechanical aptitude, attention to detail, and the ability to follow procedures closely.

Prior experience with the specific equipment or processes is not required , strong operators from chemical, industrial, or manufacturing environments are encouraged to apply.

Responsibilities:

Sol-Gel & Dissolution Operations

Operate equipment used in sol-gel processing, including mixers, vibratory pumps, wash systems, heating/drying units, and filtration systems.

Prepare chemical solutions by measuring, mixing, and adjusting feed components according to established procedures.

Support dissolution processes involving powders, aqueous solutions, and controlled chemical reactions.

Perform washing steps using oxide solutions and rinsing equipment to clean or condition material batches.

Chemical Handling & Process Execution

Handle chemical powders, solutions, and liquid waste streams following approved safety practices.

Monitor process parameters, system pressures, solution levels, temperatures, and flow rates.

Document batch data, equipment readings, and process deviations accurately.

Conduct routine cleaning, equipment resets, and system preparation between production runs.

Equipment Operation & Troubleshooting

Operate pumps, valves, pneumatic systems, heaters, furnaces, filtration modules, and separation equipment.

Perform basic troubleshooting on mechanical and chemical processing systems.

Assist maintenance or engineering staff with system adjustments, repairs, or calibration activities.

Safety, Quality & Compliance

Follow all Standard Nuclear environmental, health, and safety (EH&S) requirements, including hazardous material handling and PPE protocols.

Maintain accurate records in accordance with quality assurance procedures.

Support internal audits, inspections, and readiness reviews.

Adhere strictly to written procedures and report any deviations or safety concerns immediately.

Cross-Training & Production Support

Train across multiple chemical processing areas to provide operational flexibility.

Support production operations across Standard Nuclear's Oak Ridge facilities as needed.

Collaborate with engineering, quality, and operations teams to improve process consistency and efficiency.

Preferred Qualifications

No degree required , candidates from manufacturing, chemical processing, or industrial operations are encouraged to apply.

Minimum Requirements

3+ years of experience in chemical processing, industrial manufacturing, or mechanical/process operations.

Ability to safely handle powders, solutions, pumps, mixers, and industrial processing equipment.

Familiarity with basic chemical handling and general industrial safety practices.

Comfortable working with wash solutions, liquid waste systems, and cleaning processes.

Ability to follow detailed procedures and record accurate operational data.

Ability to lift 50 lbs., work at heights, and work in environments involving heat, noise, or odors.

Ability to work in controlled or restricted areas with required PPE.

Preferred Experience (Not Required)

Experience in sol-gel processing, wet chemistry, or materials processing.

Prior work with reactors, mixing systems, dry/wet separation equipment, or filtration modules.

Experience in plant start-up, new equipment commissioning, or scale-up environments.

Exposure to regulated operations (NQA-1, ISO, cGMP, etc.).

Lean/Six Sigma or continuous improvement familiarity.

Benefits

Health, Dental & Vision Insurance

Health Savings Account

Disability and Life Insurance

401K Plan

Paid Time Off, Holidays

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Work is performed in chemical processing and industrial manufacturing areas.

PPE such as gloves, safety glasses, and respirators may be required.

Some work occurs in controlled or restricted-access environments involving powders and chemical solutions.

Standard Nuclear embraces equal opportunity and is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin/ethnicity, veteran status, disability status, age, sexual orientation, gender identity, marital status, mental or physical disability, or any other legally protected status.

To conform to U.S. Government export regulations, applicant must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.

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