The posting
Who we are…
Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.
What you’ll be doing
The AD/Director of Analytical Development leads development, tracking, and progression of stage-appropriate analytical activities for raw material, drug substance, and drug product testing for programs from early development through commercial support, ensuring alignment with the global analytical department strategy and practices.
You will be responsible for…
· Responsibility includes phase-appropriate in-process, release, and stability testing, as well as methods qualification, validation, transfer as well as specifications setting in order to support release of R&D, GLP, and GMP material. The activities involve active third-party vendor management under aggressive business timelines to achieve project deliverables.
· Act as the Quality Control leader for MAH oversight for commercial analytical manufacturing and release testing for the China market, including on-site supervision.
· Work closely with the global Analytical department to ensure consistent practices and policies.
· Communicate, coordinate, and establish collaborative working relationships with internal Analytical, Formulation, CMC, Quality (GCP/GxP), Regulatory, Project Management, and consultants, as well as with external CROs/CMOs counterparts. Develop and manage relationships with cross functional representatives, strategic alliance partners, vendors and collaborators.
· Develop policies, SOPs, and systems to aid work flow within CMC/Quality.
· Author and review internal Nuvation Bio technical reports as well as regulatory related documentation.
· Manage critical analytical activities involving drug substance synthesis troubleshooting with appropriate characterization, release, and stability testing.
· Manage designated stability programs, review results to update/approve reports, file the approved documents in a GMP-compliant database, and track and trend the data to establish the shelf-life of API and DP.
· Lead pre-formulation and drug product formulation analytical method development including assay and related substances, dissolution, API-excipient compatibility studies, probe and formal stability studies, analytical method development and method qualification/validations.
· Ensure proper review and issuance of method validation protocols/reports/test procedures, and development reports, COAs, and stability summaries.
· Support contractor sites with active telecon meeting updates, remote and on-site involvement pertaining to OOS/OOT, investigations/deviations, and other pertinent documentation.
· Actively direct and manage the analytical timelines for all program deliverables across molecules, drug substance, drug product at various CRMOs.
· Provide critical, detailed review of external CRMO documents including raw material, drug substance, drug product paperwork, test methods, verifications, validations, transfer protocols, specifications, and developmental reports. Involves significant involvement with external sites on a routine basis.
· Author and review regulatory documents for IND, IMPD, NDA, MAA, CMC amendments, DSUR, and briefing documents for global (US, EU, China, Japan, Korea, etc.) regulatorysubmissions and responses to reviewer questions.
· Lead inspections and audits of vendor sites from an Analytical/Quality Control perspective.
· Testing, tracking, and trending of API and DP critical quality attributes, including but not limited to release and stability data, impurity tracking and identification, impurity qualification as needed, and maintaining compliant databases and reporting.
What Knowledge & Experience you'll bring to us...
- Broad analytical experience from drug substance through drug product at all phases of development. Strong background in supporting physiochemical and traditional analytical techniques
- Bilingual and proficient in both Chinese and English languages in reading, writing, speaking and listening. Able to communicate smoothly in English via telephone/video calls, emails, and face-to-face talks with AS/QC and CMC SMEs from internal and external teams. Author, review, revise and comment various documents (protocol, report, reg dossier, slide deck etc.) in English.
- Strong problem-solving skills to address a broad range of analytical topics.
- Demonstrated experience in CRO/CDMO management employing cross-functional collaboration skills
- Working knowledge of cGMP regulations required, including compendial (USP, EP, JP, ChP) and guidance documents.
- Significant experience in the development of analytical methodology to support drug substance and drug product characterization.
- Demonstrated alignment with Nuvation Bio’s values and culture.
- Excellent communication and interpersonal skills.
- Must be able to write clearly and summarize information effectively.
- Must be able to present complex information to various audiences.
- Ability to meet deadlines, make efficient and effective use of time, and manage multiple tasks with competing priorities. Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions. Be innovative in problem solving.
- Ability to work independently with limited supervision in a fast-paced environment. Strong ownership and cross boundary working mindset. Excellent written and oral communication skills to work in a cross-functional environment.
- BS/MS/PhD in Organic Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering or closely related field preferred, with 10+ years of pharmaceutical industry experienc
Behavioral skills to be successful...
- Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
- Emotional intelligence, curiosity, and a knack to figure out a way to build something better
- Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
- Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
- Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.
What we have for you!
- Competitive Base Salary, Bonus, and Equity Plans
- up to 15 OPT and 12 Sick Days Annually
- Excellent Medical Coverage
- Social Security and Provident Fund
- and much more!
The base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
Disclaimer
Nuvation Bio, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Note to all external Recruiters & Staffing Agencies All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.
