Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics)late at Abata Therapeutics

Waltham, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Master’s or PhD degree in biochemistry, biochemical engineering, biotechnology or equivalent
At least 8 years of relevant experience developing, scale-up, and transfer of downstream processes for biologics
Significant experience managing manufacturing in an MSAT environment
Direct hands-on experience with monoclonal antibodies (preferred)
Expertise in purification process optimization with an emphasis on scale-up, scale-down models, process

Responsibilities

Oversee the transfer of manufacturing processes from late-stage development to large-scale production at the CDMOs for multiple programs
Work with CDMOs to identify gaps and implement improvements towards enhancing product quality, robustness, and cost-effectiveness with line of sight to commercial manufacturing
Build strong relationships and partner cross-functionally with process development, analytical, formulation, quality, regulatory, and program management
Oversee GMP manufacturing campaigns ensuring seamless execution, timely completion, and handoff to drug product manufacturing teams
Partner with late-stage process characterization and MSAT teams and develop robust control strategy enabling successful PPQ DS campaigns
Serve as person-in-plant (PIP) during drug substance manufacturing campaigns
Partner with stakeholders to support timely approval and execution of reports, batch records, in-process sampling plans, review SOPs, change controls, deviations, OOS/OOT investigations, and CAPAs
Support regulatory filings by authoring high quality reports enabling timely submissions for multiple jurisdictions (INDs, CTAs)
Perform MFG/MSAT risk assessment activities in a phase-appropriate manner ensuring proper measures are in place in support of production and filing requirements
20-25% travel in support of manufacturing activities at CDMOs

Skills

Key technologies and capabilities for this role

Downstream ProcessingMSATBiologics ManufacturingProcess DevelopmentScale-upProcess TransferProcess ValidationBLA FilingRegulatory ComplianceData AnalysisTroubleshootingGMPTech Transfer

Questions & Answers

Common questions about this position

What is the work location and arrangement for this role?

The position is hybrid and requires being in-office 3 days per week in Waltham, MA.

What are the key responsibilities of this position?

Key responsibilities include overseeing manufacturing process transfers to CDMOs, working with CDMOs to improve product quality and robustness, building cross-functional relationships, overseeing GMP campaigns, developing control strategies, and serving as person-in-plant during manufacturing.

What skills and experience are required for this role?

The role requires experience leading MSAT for downstream biologics processes, including late-stage optimization, scale-up, transfer, troubleshooting, data analysis, regulatory compliance, process validation for BLA, and GMP manufacturing oversight.

What is the company culture like at Oruka Therapeutics?

The company is building an engaged, inclusive, and positive culture and seeks candidates passionate about making a difference and contributing to something bigger.

What makes a strong candidate for this position?

A strong candidate is an experienced MSAT leader motivated to work in a fast-paced environment on late-stage biologics manufacturing, with skills in process optimization, CDMO collaboration, cross-functional partnering, and regulatory submissions, while being passionate about biotherapeutics and company culture.

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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