Director, CMC Lead Drug Development

Job Title: Director, CMC Lead Drug Development

Job Location: Gaithersburg, MD, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Director

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

I. Job Summary

The CMC Lead – Drug Development is responsible for establishing the CMC development plan, working with cross-functional experts, and leading the execution of the plan for drug substance and drug products from pre-clinical through commercial development. This role is a key leadership function in 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 will deliver on all CMC aspects of a specific project, working both internally, across Emergent’s global locations, and externally with partners, contractors and government agencies, to fulfill drug development stages up to and including the coordination of drug substance (upstream & downstream), drug product, and associated analytical development activities through a lead intermediary.

The role requires proficiency in advancing the development of our portfolio of vaccine and therapeutic candidates with an ability to oversee programs from the completion of product feasibility through process and product development, scale-up and registration in commercial manufacture.

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.

The role requires strong project coordination and communication skills along with skills in presentation, and leadership, process design, technology transfer, and production of biologics drug supplies along with lifecycle support.

Ii. Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• 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.
  
  
  

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. The role places a heavy reliance on the incumbents influencing skills across a range of functions for successful project delivery.
• 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 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.
• 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.
• 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.
  
  
  

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $181,000 to $219,400. Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant’s geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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