Director/Sr. Director of Analytical Development

EPM Scientific

Boston, MA, USA

Published: 6/14/2022

Technology

Full Time

Job Description

Director/Sr.Director of Analytical Development (Peptides)

REMOTE

Overview

We are partnered with a well-funded clinical-stage biopharma who is advancing a pipeline of innovative smallmolecule therapies addressing several therapeutics. They are progressing multiple programs across their portfolio, from IND-Enabling to Phase III/Commercialization.

They are seeking a Director of Analytical Development to lead analytical activities for a multiasset peptide portfolio, covering both Drug Substance (DS) and Drug Product (DP) from IND through Phase 3 and commercial launch. This role will define analytical strategy, ensure method readiness across development stages, and support successful regulatory submissions and commercialization efforts.

Key Responsibilities

Lead analytical development strategy for peptide DS and DP across multiple programs.
Oversee development, qualification, and validation of analytical methods from early clinical through commercial stages.
Establish and maintain specifications, stability programs, and control strategies.
Provide analytical leadership for CMC submissions (IND/CTA, Phase 2/3 updates, NDA/BLA).
Partner crossfunctionally with Process Development, Formulation, Manufacturing, Quality, and Regulatory.
Lead analytical tech transfers to CDMOs and QC labs; manage external partners.
Build and lead a highperforming Analytical Development team.
Ensure analytical readiness for latestage development, PPQ, and commercial launch.

Qualifications

PhD in Analytical Chemistry, Pharmaceutical Sciences, or related field (or MS/BS with additional experience).
Extensive experience in peptide analytical development, including DS and DP.
Proven track record supporting programs from IND through latestage clinical and/or commercial.
Experience with method development, validation, stability, and tech transfer.
Prior people leadership and CDMO oversight experience strongly preferred.

Ideal Background

Experience working on multiple peptide & small molecules assets in parallel.
Comfortable operating in a fastmoving, evolving CMC organization.
Strong communication skills and ability to work crossfunctionally.

Company DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.
Job Responsibilities:
•\tConducting Post Market Activities and Post Market Surveillance
•\tManaging Customer and Product Complaint Investigation programs
Education and Experience:
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry
•\tBachelor's degree
•\tComputer proficiency

Company Description

A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\r\nJob Responsibilities:\r\n•\tConducting Post Market Activities and Post Market Surveillance\r\n•\tManaging Customer and Product Complaint Investigation programs\r\nEducation and Experience:\r\n•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry\r\n•\tBachelor's degree\r\n•\tComputer proficiency