Director, Analytical Development
Please be advised that Amicus has entered into a Business Combination Agreement for the purpose of launching Caritas Therapeutics, Inc. (“Caritas”) a next generation genetic medicine company. Upon the closing of that transaction, Amicus and Caritas will be two separate publicly traded companies and this position will reside in the Caritas organization.
This position will be responsible for providing strategic direction and management of Analytical Development group activities for Amicus’s Biologics and Gene Therapies portfolio. Position will coordinate and oversee method development and clinical testing at contract testing laboratories for drug substance, drug product and for Stability Programs for the developmental portfolio. This individual will work closely with other areas such as Pharmaceutical Development, Manufacturing, Supply Chain Operations, Quality Assurance and CMC Regulatory Affairs to manage the method transfers, methods validation, data oversight and ensure timelines coincide with process development and production schedules. This includes vendor oversight, data review, external auditing, exceptions management (Deviations, CAPAs, OOS/OOT), and change control as it relates to GMP quality testing for Biologics and Gene Therapy products. The incumbent will oversee designation of critical quality attributes, trending of method performance as well as in process, release and stability data, and setting of specifications. This position directs method transfers and method validation lytioca and is knowledgeable regarding corporate quality systems for laboratory controls. The individual should have experience with authoring relevant sections of BLAs along with experience interacting with various Health Authorities. This role will have supervisory responsibilities.
Roles and Responsibilities
The Director, Analytical Development for Biologics and Gene Therapies is responsible for:
- Ensures contracted third-party testing (CMOs and Labs) are in compliance with appropriate quality practices to meet the desired quality attributes of the Company and ensures the facilities/quality systems will pass regulatory inspections.
- Development and maintenance of AD Policies & SOPs
- Development and maintenance of specifications, reference standard and retains programs
- Oversees method transfers and method validations at contract labs and CMOs.
- Provides oversight and approval of cGMP documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.).
- Reviews raw data from third parties, and generates Certificates of Analysis.
- Contributes to appropriate sections of Annual Product Reviews for applicable products.
- Authors AD-related sections (e.g., batch analysis, analytical methods, reference standard, and specifications) of regulatory filings.
- Keeps abreast of industry developments – new technology, forthcoming regulations, competitor activity, etc.
- Participates in cGMP audits of contract testing labs.
- Supports corporate and third party inspection readiness activities.
- Serves as an SME for analytical methodologies, specifications, stability, reference standard, etc. during regulatory inspections.
- Understands and proposes improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies.
- BS in the Sciences and 15 years (or combination of MS with 12 years, PhD with 10 years) of experience in pharmaceutical Analytical Development and quality operations for development through commercial products; biologics experience required, small molecule experience a plus.
Professional Work Experience Requirements
- Has experience working in a development, GMP and GLP environment as it applies to laboratory and stability functions and has experience in preparing and complying with required regulatory guidelines involving PAI and Inspection planning and follow-up.
- Experienced in analytical methods development and validation, method transfer activities, and continuous improvement. This will involve oversight of GMP testing at CROs and CMOs as it applies to laboratory and stability functions
Experience and Skills
- Demonstrated ability to work in multi-disciplinary settings acting as facilitator and coach.
- Strong leadership, team building, organizational, communication and interpersonal skills.
- Has experience in overseeing and planning budgets and monitoring expenses. Provides direction on Goals and Objectives to support company strategic direction.
- Supervise a small team and provide development and mentoring support.
- Preferred experience in establishing and running an analytic testing facility
- Demonstrated alignment with Amicus Mission Focus Behaviors
- Passion for rare disease and patient focused
Location and Travel
- Corporate Headquarters is in Philadelphia, PA
- It is expected that any remote workers are able to travel to the office up to 10% of the time
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.
Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.