- Lead analytical assay development for potency, identity, structure/function characteristics, safety, stability, and impurity utilizing a wide range of technical platforms such as cell-based assays, ligand-binding immunoassays, flow cytometry, enzymatic reactions, and LC/MS.
- Manage routine testing, such as stability and release testing, characterization, in-process samples analysis and reference standard qualification. Responsible for the overall quality and compliance of all the testing.
- Lead formulation development that results in a robust formulation that maximizes product shelf life.
- Interface with discovery and developability colleagues to establish QTPP for pipeline assets, which are typically protein-based therapeutics.
- Develop scientific justifications for release specifications to support drug substance, drug product release and critical process intermediates.
- Provide technical oversight of assay-related activities executed at external CRO/CDMO laboratories (technical transfer, assay qualification, quality control, troubleshooting, data/report review, etc.) ensuring integrity of data produced.
- Serves as internal analytical SME and SPOC with a focus on supporting Technical Operations project requirements, ensuring efficient communication and workstream execution to deliver corporate goals and objectives.
- Maintains a good understanding of Regulatory and Quality aspects appropriate to all aspects of work.
- Review and approval of data, drafting appropriate protocols, reports and processing documents as required; and. Ensure methods and data generated are in line with quality and regulatory expectations.
- Author and review relevant sections of regulatory submissions. Participate in regulatory interactions if needed.
- Collaborate with Discovery colleagues on asset developability and potency test methods; lead methods transfer and qualification/validation at CRO/CDMO.
- Represent analytical development function on CMC and project teams. Collaborate with cross-functional stakeholders on study protocols and develop aligned analytical plans. Ensure timely delivery of decision-making data to support CMC timeline.
- Provide technical direction, mentorship and coaching to the analytical development team.
- Drive innovative approaches to address challenging analytical issues based on emerging scientific insights, new technologies and program needs.
- Additional duties as required.
- BS with 25+ years, MS with 20+ years, or Ph.D. with 15+ years of analytical experience in biotechnology/pharmaceutical industry.
- Strong knowledge and scientific oversight of LC/MS of proteins, cell based and immunoassay development, qualification, transfer, validation. assessment/optimization of critical quality attributes of proteins and biologic drug products. Strong knowledge of elucidation of structure for protein-based products.
- Ability to develop phase appropriate product control strategies.
- Ability to develop comparability programs for scale changes in manufacturing.
- Significant and established experience in late-stage product characterization, regulatory filing, and response to agency questions.
- Experience leading/developing staff members, including both direct reports and skip-level staff.
- Demonstrated organizational and strategic leadership in establishing technical guidelines and business processes, as well as steering cross-organizational alignment within and outside of Technical Operations.
- Experience working with business partners across in-house and external development and manufacturing.
- Good understanding of quality systems and experience with successful internal and regulatory audits/inspections.
- Experience with Microsoft Suite is required, experience with Microsoft Teams is desirable.
- Experience working under global regulatory agencies such as the EMA and HC is highly desirable.
Sr. Director of Analytical Sciences and Technology - Bala Cynwyd, United States - Larimar Therapeutics
Description
:The Company:
This publicly held clinical-stage biotechnology company is focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Their lead product candidate, CTI-1601, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality.
The company has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has about 45 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs and the development of manufacturing processes utilizing good manufacturing practices (GMPs).
The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how and expertise to the development of CTI-1601 and other future pipeline programs. They are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.
Position:
Sr. Director of Analytical Sciences and Technology (AST) within the Larimar Technical Operations Group.
Position Summary:
This position will head the AST function within the Larimar CMC Technical Operations Group. As the head of the AST function, this key team member will assume responsibility and accountability for protein/large molecule product characterization, CQA assessment, QC method development/optimization, setting scientifically justifiable comparability strategies, specification, and control strategies of pipeline assets. The oversight of product stability trend analysis, reference standard characterization and stability programs and critical reagent inventory monitoring will be entrusted to this function. In this fast-paced environment, the person who fills this role will have the opportunity to develop scientifically and gain insight into other areas of the business.
Job Responsibilities:
The responsibilities may include but are not limited to the following activities:
Qualifications:
Benefits:
Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.
We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.
Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and
business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner—without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.
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