Director, Drug Substance SME, CMC
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Job Detail
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Job Description
The Director, Drug Substance Development SME is responsible for providing key expertise and strategic contributions to the Development team to establish the CMC development plan and support its’ execution for Drug Substance processes from pre-clinical through post-approval commercial stages. This is a key position in the monoclonal antibody, hyperimmune, and vaccine CMC team.
These programs may be a mix of early-stage proof of concept, through IND, late stage through regulatory approvals, as well as life cycle management programs, that require flawless execution because they are critical to commercial success.
II.   ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
•   This role provides drug substance expertise in monoclonal antibodies, hyperimmunes and vaccines to multiple programs, and may involve interactions and collaboration with internal and external teams, to support the development of therapeutic candidates and advancement of platforms, combined with the introduction of new candidates and technology enhancements for programs within Emergent
•   The role requires strong skills in communication, presentation, and technical areas, process design, technology transfer, and production of biologics drug supplies along with lifecycle support. Effective communication is required for interactions with senior leaders, peers, and both internal and external personnel.
•   This role works with the CMC team to develop strategies, set direction, and plan initiatives that lead to the advancement of our project portfolio.
•   Supports cross-functional efforts that manage third-party logistics production delivery and relationships for the project portfolio. Support sourcing and selection of third-party manufacturers.
•   Supports resource planning including budget and staffing model needs for individual program initiatives.
•   Participate in (in-person or remotely) ongoing development programs including developing detailed technical work plans; selecting suitable service for the various activities; supporting the management of vendor performance, and preparing periodic updates for Sr. Mgmt. as may be required by internal governance demands.
•   Prepare, in conjunction with functional leaders and Regulatory Affairs, the Chemistry and Manufacturing Controls sections of IND and NDA filings for the products that they support.
•   Develop, set, and communicate sustainable targets and goals for self and programs.
•   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, where required.
BEHAVIORS:
To perform the job successfully, an individual should demonstrate the following competencies:
•   Leadership –Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Inspires respect and trust; Accepts feedback from others; Provides vision and inspiration to peers and subordinates; Gives appropriate recognition to others.
•   Managing across reporting structure – Includes personnel in planning, decision-making, facilitating and process improvements; Takes responsibility for team members’ activities; Develops team members’ skills and encourages growth; Fosters quality focus in others; Sets expectations and monitors delegates activities; Provides recognition for results.
•   Problem Solving – Identifies and resolves problems in a timely manner, analyzing information skillfully; Develops alternative solutions; Uses reason even when dealing with emotional topics.
•   Interpersonal – Focuses on solving conflict, not blaming; Maintains confidentially; Listens to others without interrupting; Keeps emotions under control; Remains open to others’ ideas and tries new things; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
•   Teamwork – Balances team and individual responsibilities; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives.
•   Business Acumen and Ownership – Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition.  Aligns work with strategic goals; works within approved budget; Develops and implements cost saving measures; Conserves organizational resources.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
•   PhD or MS in Chemistry, biological or medical sciences, biotechnology (or a related scientific discipline) with a minimum of 8 years+ experience in the development of therapeutic candidates is desirable.
•   Experience in biotech/pharma industry at a senior level; 3+ years’ experience in a management role; Broad knowledge of biologics and therapeutics.
•   Direct experience with generating documentation for regulatory filings for drug development.
•   Experience preferred in the pharmaceutical or biotechnology industry with systems and processes stated coupled with a broad exposure to established and novel drug platforms.
•   Expert knowledge of scientific principles and concepts in drug substance development, including, strategy development, study design and early and late-stage requirements
•   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.