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Company

Emergent BioSolutions · 8 hours ago

Director, CMC Lead Drug Development

Gaithersburg, MD

Full-time

Remote

Director/Executive

$181K/yr - $219K/yr

10+ years exp

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BiotechnologyHealth Care

H1B Sponsor Likely

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Responsibilities

This role works cross-functionally to develop strategies, set direction, plan, and prioritize initiatives that lead to the advancement of our project portfolio. This includes the: integration of the work priorities with other groups internal and external to the organization; Effective communication on such initiatives with senior leaders, peers, staff, and external stakeholders.

Leads cross-functional efforts that manage third-party logistics production delivery and relationships for the project portfolio. Select third-party manufacturers working with Quality and Regulatory, negotiate effective technical agreements, and identify contract analytical laboratory sites through development to commercialization stages.

Resource planning including budget and staffing model preparation (for departments, functions, or systems) and capacity monitoring of routine operations and enhancement projects.

Manage (in-person or remotely) ongoing development programs including developing detailed technical work plans; selecting suitable service for the various activities; managing the performance of the vendors and preparing periodic updates for Sr. Mgmt. as may be required by internal governance demands.

Prepare, in conjunction with Regulatory Affairs, the Chemistry and Manufacturing Controls sections of all IND and NDA filings for the products that they manage.

Develop, set, and communicate sustainable targets and goals for self and programs.

Ensure the technology transfer of developed processes to external Contract Manufacturing Organizations (CMO) for GMP clinical manufacturing or additional as may be required.

Be a key member in delivering the company’s product portfolio, including participation in the planning of timelines, deliverables, and milestones in collaboration with other cross-functional groups.

Work closely with the Grants & Contracts team to respond to RFPs and win external funding as may be required.

Qualification

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MS in ChemistryBiotech/pharma industry experienceRegulatory filings documentationLeadership of technical teamProject coordinationExpert knowledge of biologicsOrganizational ability

Required

PhD or MS in Chemistry, biological or medical sciences, biotechnology (or a related scientific discipline) with a minimum of 10 years+ experience in the development of therapeutic candidates is desirable.

Experience in biotech/pharma industry at a senior level; 8+ years’ experience in a management role; Broad knowledge of biologics and therapeutics.

Direct experience with generating documentation for regulatory filings for drug development.

Proven leadership (in-person and remotely) of a technical team, including all aspects of performance management.

Proven ability to direct internal and external development activities with cross-functional partners and/or external vendors to drive project completion under rigid timelines.

Expert knowledge of scientific principles and concepts in plasma protein, cell culture, purification of protein therapeutics etc.

A true self starter, who works effectively on their own initiative, and is used to working in demanding environments where there is continuous change and ambiguity.

Excellent organizational ability and working well in a fast-paced, team-oriented, collaborative way is required.

Excellent communication skills and strong interpersonal skills.

Highly organized, with exceptional time management and prioritization.

Critical thinking evaluation of process problems.

Strong work ethic.

Flexibility to travel on company business when required.

Preferred

Experience preferred in the pharmaceutical or biotechnology industry with systems and processes stated coupled with a broad exposure to established and novel drug platforms is preferred.

Benefits

Comprehensive benefits package

Eligibility for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options.

Company

Emergent BioSolutions

Glassdoor

3.4

Emergent BioSolutions develops, manufactures, and delivers a portfolio of medical countermeasures for biological and chemical threats.

Founded in 1998

Gaithersburg, Maryland, USA

1,001-5,000 employees

http://emergentbiosolutions.com

H1B Sponsorship

Emergent BioSolutions has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2021 (2)

2020 (1)