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Head of CMC

Company: HCPro
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Company: Orum Therapeutics

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Head of CMC - Cambridge, MA — Orum Therapeutics Home About TeamScience Careers News Contact Head of CMC - Cambridge, MA Job TitleHead of CMC Location Cambridge, MA, USA Company Overview OrumTherapeutics is a private biotech company located in Daejeon,Korea, and Cambridge, Massachusetts. We are developing a novelclass of therapeutics to bring new medicines to patients with unmetmedical needs. Orum leverages its proprietary antibody andconjugation platforms to inhibit or degrade intracellular targetproteins. We are advancing our first set of oncology candidatestoward preclinical development.

The Role The Head of CMC will be based in Cambridge, MA and willplay a key role in the progression to IND and beyond for Orum’sinitial clinical products. This role requires the candidate to leadthe CMC efforts including a combination of setting the overalldirection of the CMC activities, and both developing functionalstrategies and driving tactics to accomplish manufacturing goalswhile meeting regulatory requirements.

Reporting to Chief Scientific Officer, the ideal candidate willhave demonstrated strong functional expertise within biomoleculemanufacturing, executing supply chain projects and strategies,optimizing technology and productivity and output increases withexcellent compliance levels. Understanding of related processdevelopment and analytical activities is also required.

The candidate will have significant leadership experiencevetting and managing external development and manufacturingpartners (CDMOs), ideally in biologics clinical manufacturing (e.g.ADCs) focusing on the biologics process in R&D andmanufacturing and taking a product through the various clinicaltrial phases.

S/he will assume overall responsibility for managingmanufacturing processes, scaling up production, and improvingprocesses and increasing efficiency, while maintaining the higheststandards. S/he will be responsible for all manufacturingoperations as well as related process development and analyticalactivities.

Responsibilities Set a vision and strategy for the CMCorganization to include compliant and robust manufacturing andanalytical capabilities at CDMOs.

Manage key activities at third party providers as it relates toassurance of key quality and delivery performance indicators.

Champion the assessment and implementation of innovativeapproaches to manufacturing with CDMOs.

Work closely with technical consultants and eventually develop astrong multifunctional team(s) to deliver high quality supplyperformance to meet key targets of clinical development plan.

Work collaboratively with the science and clinical teams as wellas business development to meet the current and future needs of theprograms.

Deliver key production performance, financial, compliance,quality, expectations to meet demands.

Establish highly effective technical capability across alloperations and teams.

Lead and coach team to drive high performance culture thataccommodates rapid and dynamic growth.

Support regulatory filings.

Requirements and Qualifications Minimum Bachelor’s degree inBiochemical Engineering or Biochemistry or equivalentexperience.

Minimum of 5 years relevant experience in Biomanufacturing (e.g.antibodies and antibody drug conjugates). Previous experience inADC manufacturing is highly desirable.

Technical skills in biomolecule process development and relatedanalytics highly desirable. Specific knowledge of bioconjugation aplus.

Experience working with CDMOs at multiple remote locationsessential.

Strong leadership skills – both in terms of people andscience.

Flexible mindset capable to manage change and deal withambiguity.

Proven ability to withstand pressure and manage complexprojects. Flexibility to re- prioritize workload to meet changingtimelines, adaptability.

Autonomous, pro-active personality. Driven to achieving highestresults in shortest time frame.

Work in a fast-paced, international, biotech setting.

Please send your resume and cover letter to jobs@orumrx.com toapply

(Title field: Full Name_Head of CMC, Cambridge ) Orum iscommitted to a workplace in which diversity of people and ideas arevalued and welcomed. Orum provides equal employment opportunitiesto all employees and applicants for employment and prohibitsdiscrimination and harassment of any type without regard to race,color, religion, age, sex, national origin, disability status,genetics, protected veteran status, sexual orientation, genderidentity or expression, or any other characteristic protected byfederal, state or local laws. This policy applies to all terms andconditions of employment, including recruiting, hiring, placement,promotion, termination, layoff, recall, transfer, leaves ofabsence, compensation and training.

July 28, 2020 Next Scientist, Cancer Biology - Daejeon, KR HOMEABOUT TEAM NEWS CONTACT Terms of Use Privacy Policy Asia

Orum Therapeutics, 2nd Floor, 281-25 Munji-ro,

North America

Orum Therapeutics, 5th Floor, 20 Acorn Park Drive

Keywords: Orum Therapeutics, Cambridge , Head of CMC, Other , Cambridge, Massachusetts

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