Director, Clinical Production

Location: 

San Diego, CA, US, 92121


 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The Director, Clinical Production manages and leads Emergent’s GMP Clinical Production team, to successfully execute on vaccine production for Clinical Ph I/Ph II development, enabling advancement of both internal pipeline and external client programs. The main responsibilities include development and operationalization of standard work practices and programs for GMP materials, as well as continued assessment for excellence across the site GMP systems for the production of Phase I/II drug substance/product. These responsibilities include leading a team of upstream and downstream professionals to excel at achieving performance-to-plan and production of product meeting Emergent’s high expectations for Quality and Compliance.    
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

  • Partners with leadership and cross-functional partners to establish manufacturing schedule, and ensure project alignment and support
  • Executes against master schedule and other plans to achieve performance against plan, maintaining full GMP compliance
  • Budgets and controls the financial, human and technical resources of the team
  • Recommends and, as approved, ensures changes to the structure and organization of tasks
  • to ensure efficient achievement of accountabilities and goals and to provide flexibility to
  • quickly capitalize on business opportunities
  • Provides system, capability and resource input in the generation of potential contract manufacturing contracts
  • As required, supports leadership in internal and external audits
  • As applicable, reviews deviations and ensures preventive and corrective actions are implemented and demonstrated as effective
  • Ensure the initial and continuing training of the departmental personnel is conducted and
  • adapted according to need and to ensure GMP Compliance is maintained
  • Ensure the safety and security of the departmental personnel, premises and equipment
  • Ensure every effort is made to complete annual goals that are agreed to with reporting
  • Manager
  • Ensure that production records are evaluated and approved by an authorized person before they are sent to the Quality Assurance Department.
  • Support investigational new drug (IND) chemistry-manufacturing-control (CMC) section writing, where applicable
  • Analyze data, interpret results and trouble shooting. Present and discuss results of manufacturing campaigns with the department and project teams.  
  • Maintain high level of scientific expertise through familiarity with current scientific literature.
  • 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. 
  • 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 People – Includes staff 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; Gives authority to work independently; 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 budge; Develops and implements cost saving measures; Conserves organizational resources. 

 EDUCATION, EXPERIENCE, SKILLS

  • Degree in biology, bioengineering, chemical/biochemical engineering, or a related field. PhD with minimal 5 years' relevant experience, or M.S. with 7 years or B.S. with 10 years relevant experience
  • Minimum of 4 years management experience, team leader and team player
  • Minimum of 4 years experience operating in regulated cGMP environment
  • Demonstrated ability to resolve technical, scientific and regulatory issues in the pharmaceutical industry and to effectively communicate such information to senior management
  • Carries out management accountabilities in accordance with corporate policies and procedures. Accountabilities include recruitment, training and professional development, planning, assigning and directing work, performance management and measurement and ensuring compliance with employment legislation
  • Contribute and collaborate with cross functional project teams, troubleshoot effectively, and solve complex technical issues
  • Mammalian cell culture experience with various adherent cells and suspention cells such as Vero, HEK293, CHO cells and with Bioreactor (small scale and large scale) experience
  • Experience with depth filtration and ultrafiltration/dialfiltration
  • Excellent understanding of scientific methods and statistical analysis.
  • Highly self-motivated, with excellent organizational skills and critical-thinking skills.
     

 

Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment,  subject to legally required exemptions.

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.
 

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: San Diego