VP, Chemistry Manufacturing and Controls (CMC) at Abata Therapeutics

Burlington, Massachusetts, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Advanced degree (Ph.D., M.S., or equivalent) in Chemistry, Chemical Engineering, Biochemistry, or a related field
PhD or MS with 10+ years of CMC experience in the biotech/pharmaceutical industry, including work with contract manufacturers
Advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
Experience in early and late-stage drug substance development, formulation development, process development, clinical and commercial cGMP production including process validation experiments, pre-approval inspections, and commercial manufacturing
Extensive experience managing US and International CMOs for the manufacture of drug substance and drug product
Experience with authoring/reviewing regulatory documents (IND, CTA, NDA), specifically Module 3 sections of an IND/NDA, and FDA information requests
Experience interfacing with regulatory agencies
Robust knowledge of relevant FDA and EMEA regulations and guidances
Strong analytical, organizational, and time management skills with a track record

Responsibilities

Develop and implement the CMC strategy aligned with the company’s overall goals and objectives
Provide leadership and direction to the CMC team, fostering a culture of quality, innovation, collaboration, and continuous improvement
Oversee the development and optimization of small molecule drug substance and drug product manufacturing processes for biopharmaceutical products
Ensure the successful scale-up of processes from laboratory to clinical and commercial scale
Lead efforts in chemical process development, oral solid formulation development, analytical method development, process validation and drug supply
Ensure all CMC activities comply with regulatory requirements (e.g., FDA, EMA) and industry standards
Lead the preparation and submission of phase-appropriate CMC sections of regulatory filings, including INDs, and NDAs
Ensure the timely and cost-effective production of clinical and commercial supplies
Work with Quality Assurance to maintain quality system components to ensure product quality and compliance, including controlled documentation, change control, noncompliance/deviation management, CAPA, and training
Collaborate with R&D, Quality Assurance, Regulatory Affairs, and other departments to ensure alignment and effective execution of CMC activities
Work with internal and external partners to drive CMC objectives forward and provide oversight and tracking of critical pipeline objectives
Work with Quality Assurance and Regulatory Affairs to maintain inspection readiness
Participate in project teams and contribute to the overall product development strategy
Work with CMC functional department heads to develop and manage the CMC budget, ensuring clear oversight and efficient allocation of resources
Identify and address resource needs, including personnel, equipment, and facilities
Recruit, mentor, and develop CMC team members, fostering a high-performance culture
Provide guidance and support to ensure professional growth and development within the team

Skills

CMC

Small Molecule Drug Substance

Drug Product Manufacturing

Chemical Process Development

Oral Solid Formulation

Analytical Method Development

Process Validation

Drug Supply

FDA Regulations

EMA Regulations

IND

NDA

Regulatory Filings

Process Scale-up

Quality Assurance

Abata Therapeutics

Develops therapies for autoimmune diseases

About Abata Therapeutics

Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.

Cambridge, MassachusettsHeadquarters

2021Year Founded

$184.8MTotal Funding

EARLY_VCCompany Stage

BiotechnologyIndustries

11-50Employees

Risks

Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.

Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.

Rising clinical trial costs pose financial risks to Abata's pipeline progression.

Differentiation

Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.

Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.

Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.

Upsides

Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.

FDA's accelerated approval pathways may expedite Abata's clinical trials.

Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.

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