Oruka Therapeutics

Associate Director, Regulatory CMC (Biologics)

Waltham, Massachusetts, United States · Director

Sponsorship not specified$181k-$208kDetected 9 days ago

Supply ChainFDA RegulatoryAnimal StudiesLeadershipCommunicationCollaborationProblem SolvingCritical Thinking

About the role

Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases.
Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Job Title: Associate Director, Regulatory CMC (Biologics) Location: Hybrid - Waltham, MA.

Responsibilities

Develop regulatory CMC dossiers, timelines and deliverables in support of global regulatory submissions (IND, IMPD, BLA)
Provide strategic guidance while acting as the key regulatory CMC SME in cross-functional meetings with internal and external partners
Partner with stakeholders to respond to requests from regulatory agencies involving drug substance and aseptic drug product manufacturing including drug/device combination products
Liaise with key internal (CMC, QA, RA, and Supply Chain) and external stakeholders (CDMOs) to develop dossiers including amendments related to manufacturing, specifications or stability protocol changes
Lead regulatory strategy in support of combination product development e.g., design control and validation, DHF, human factor studies, and bridging studies
Manage regulatory CMC submissions and ensure content is in line with combination drug device guidelines including ISO standards, FDA (21 CFR Part 4), and EMA (MDR/IVDR)
Collaborate with CMC, Supply chain, QA and RA functions to support maintenance of product compliance, shelf life and change control procedures
Serves as the Regulatory CMC SME in internal and external forums and partner with regulatory program leads in support of global submissions
Lead regulatory CMC risk assessment and develop potential mitigation strategies in a timely manner
Develop road map for late-stage process development, process characterization, and PPQ campaigns

Requirements

Master's or a PhD in a life sciences discipline with 6-8 years of experience in a CMC focused role and a minimum of 3+ years of regulatory CMC experience in biologics
Regulatory CMC expertise from early stage preclinical development through various stages of clinical development and marketing approvals
Successful track record of managing interactions with the FDA, EMA and other global regulatory agencies related to CMC submissions
Must have experience in authoring and reviewing combination drug/device related Module 3 submissions
Experience with liquid formulation studies, process development, container closure compatibility studies, device functionality studies and QTPP development
In-depth knowledge of aseptic regulations required to manage multi country regulatory filings
Strong scientific skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets
Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders
Must have a creative and strategic attitude with the ability to work in a fast-paced environment
Candidates will be required to be in-office 3 days/week.
Significant exposure to cGMPs, biologics development, manufacturing regulations and guidelines involving biologics with emphasis on monoclonal antibodies
Exposure to global combination drug/device regulations including relevant ISO standards, FDA (21 CFR Part 4), and EMA (MDR/IVDR)
Exposure to the phase appropriate development of design control and validation protocols, URRAs, DHFs, and human factor studies
Strong sense of urgency and ability to deliver in a highly fast paced environment

Compensation

An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
The anticipated salary range for candidates, who will work in Waltham, MA is $181,000 to $208.000.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.
Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.
Salary Range for the Role
$182,000 - $208,000 USD

Benefits

Competitive salary and benefits package.

Company info

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com
As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Job Title: Associate Director, Regulatory CMC (Biologics)
Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases.
Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year.
For more information, visit www.orukatx.com
We are seeking an experienced and motivated candidate to develop regulatory CMC strategy in support of early-to-late-stage clinical programs.
In this role, you will be responsible for authoring high quality regulatory CMC submission while guiding CMC teams on relevant phase appropriate global regulatory guidelines.

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