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Associate Director, Drug Substance Manufacturing
LARIMAR THERAPEUTICS INC
 
Job Location: Bala Cynwyd, PA

About Us:

Larimar Therapeutics, based in the Philadelphia area, is committed to discovering and developing treatments for complex rare diseases, with an initial focus on Friedreich's ataxia. Its proprietary protein replacement therapy platform is intended to deliver missing proteins inside the machinery of cells to treat devastating rare diseases that currently have ineffective or no treatments available.

Position Summary:

This position reports to the Vice President, Manufacturing and Supply Chain and will be responsible for the execution of upstream (fermentation) and downstream (column chromatography) drug substance (DS) manufacturing activities being executed at contract service providers on behalf of Larimar Therapeutics, Inc. This role is crucial in the CMC development of Larimar's pipeline and will start as an individual contributor, with the opportunity to manage a team as Larimar grows.

Responsibilities:

Will include but are not limited to:

• Oversight and management of upstream and downstream drug substance (DS) manufacturing activities performed at contract service providers (CSPs).

• Serves as person in plant (PIP) at CSP during the execution of key DS manufacturing unit operations

• Oversight and management of vendor selection and due diligence process to identify key vendors to support DS manufacturing and DS storage

• Oversight and troubleshooting of technology transfer, process performance qualification and validation activities in support of Larimar development programs as they are executed at CSP's

• Serving as internal technical subject matter expert (SME) and point of contact (POC) with a focus on supporting CMC project requirements, ensuring efficient communication and workstream execution to deliver on corporate goals and objectives

• Ensuring that project managers, quality stakeholders and senior leaders are informed of issues at CSP's as they occur

• Maintaining a good understanding of Regulatory and Quality aspects appropriate to all aspects of work

• Reviewing and approves CSP documentation, authors internal protocols, reports, change controls, and regulatory filing as required; and ensures integrity of data produced to support regulatory filings

• Performing presentations at team, department and project meetings while collaborating with other groups within Larimar


Position Summary:This position reports to the Vice President, Manufacturing and Supply Chain and will be responsible for the execution of upstream (fermentation) and downstream (column chromatography) drug substance (DS) manufacturing activities being executed at contract service providers on behalf of Larimar Therapeutics, Inc. This role is crucial in the CMC development of Larimars pipeline and will start as an individual contributor, with the opportunity to manage a team as Larimar grows.Responsibilities: Will include but are not limited to: Oversight and management of upstream and downstream drug substance (DS) manufacturing activities performed at contract service providers (CSPs). Serves as person in plant (PIP) at CSP during the execution of key DS manufacturing unit operations Oversight and management of vendor selection and due diligence process to identify key vendors to support DS manufacturing and DS storage Oversight and troubleshooting of technology transfer, process performance qualification and validation activities in support of Larimar development programs as they are executed at CSPs Serving as internal technical subject matter expert (SME) and point of contact (POC) with a focus on supporting CMC project requirements, ensuring efficient communication and workstream execution to deliver on corporate goals and objectives Ensuring that project managers, quality stakeholders and senior leaders are informed of issues at CSPs as they occur Maintaining a good understanding of Regulatory and Quality aspects appropriate to all aspects of work Reviewing and approves CSP documentation, authors internal protocols, reports, change controls, and regulatory filing as required; and ensures integrity of data produced to support regulatory filings Performing presentations at team, department and project meetings while collaborating with other groups within Larimar, Education, Experience, Skills and Knowledge:Requires a Bachelors degree in life sciences or healthcare (advanced degree preferred), with a minimum of 10 years of relevant DS development experience in the pharmaceutical/biotechnology industry. Preference will be given to candidates that have experience in the development of recombinant fusion proteins or monoclonal antibodies. CMC DP development of programs in all phases of development from nonclinical (toxicological) to clinical (Phase 1 through 3) to commercial is required, as is thorough knowledge of ICH/GMP guidelines that direct the CMC DP development. Strong understanding and implementation of bacterial fermentation, mammalian cell culture, column chromatography, tangential flow filtration (ultrafiltration/diafiltration), centrifugation, depth filtration, extractable & leachable assessments, risk assessments, etc. supporting the CMC development of bulk drug substances (BDS) is ideal. If you are an individual with the ability to apply analytical and problem-solving skills in the identification of emerging risks and to collaboratively champion solutions, this could be the role for you!,

Education, Experience, Skills and Knowledge:

Requires a Bachelors' degree in life sciences or healthcare (advanced degree preferred), with a minimum of 10 years of relevant DS development experience in the pharmaceutical/biotechnology industry. Preference will be given to candidates that have experience in the development of recombinant fusion proteins or monoclonal antibodies. CMC DP development of programs in all phases of development from nonclinical (toxicological) to clinical (Phase 1 through 3) to commercial is required, as is thorough knowledge of ICH/GMP guidelines that direct the CMC DP development. Strong understanding and implementation of bacterial fermentation, mammalian cell culture, column chromatography, tangential flow filtration (ultrafiltration/diafiltration), centrifugation, depth filtration, extractable & leachable assessments, risk assessments, etc. supporting the CMC development of bulk drug substances (BDS) is ideal. If you are an individual with the ability to apply analytical and problem-solving skills in the identification of emerging risks and to collaboratively champion solutions, this could be the role for you!

Equal Opportunity Employment

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 employment relationship with all 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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