Director Analytical Chemistry

Profile

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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.

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Seeking a strong leader to build and manage a high performing Analytical Chemistry team. The director will oversee product quality testing in accordance with cGMP guidelines and validated procedures.  The role includes management of stability, Raw Material testing and release, and environmental monitoring. The Director will ensure that testing is completed in a timely manner, that product is shipped on time in order to meet both internal and external customer requirements. The Director will ensure that personnel are adequately trained, guided and motivated.

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ESSENTIAL FUNCTIONS
nReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
n•    Build a high functioning and motivated team through hiring and mentoring of all team members
n•    Management of direct reports and co-ordination of lab functions/resources to ensure that materials are tested to the highest standards of cGMP and to prescribed deadlines.
n•    Establish, develop, and drive processes, systems, and people to achieve 100% quality and productivity.
n•    Ensure compliance with all regulatory requirements, particularly as they relate to product testing.
n•    Play appropriate role in the development, operation, and evaluation of GMP training/re-training programs.
n•    Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate.
n•    To support the release of raw materials, in-process and finished product test results as well as environmental monitoring data
n•    To ensure that the Environmental Monitoring program is conducted in line with industry best practice.
n•    To manage analytical validation and tech transfer activities as they relate to analytical testing of internal and client development products.
n•    To operate, suggest, develop, and implement company quality policies/initiatives and to ensure the operation of these policies throughout the facility. 
n•    To represent the analytical function and the broader Company at internal and external meetings, seminars, audits, inspections by regulatory authorities, clients, suppliers and any other third party.   
n•    To develop and operate in accordance with agreed financial budgets.   
n•    Provide oversight to all GMP-related activities conducted by the team, including EM, RM testing, early phase (pre-clinical, Phase 1, Phase 2) drug substance release.  Work in collaboration with the QA department to ensure compliance with regulatory and corporate standards.

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BEHAVIORS:

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To perform the job successfully, an individual should demonstrate the following competencies:
n•    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.
n•    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.
n•    Problem Solving – Identifies and resolves problems in a timely manner, analyzing information skillfully; Develops alternative solutions; Uses reason even when dealing with emotional topics. 
n•    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.
n•    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. 
n•    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.

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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. 

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MINIMUM EDUCATION, EXPERIENCE, SKILLS
n•    Bachelor’s Degree in a Life Science discipline with at least 10 to 15 years of experience working in a biopharmaceutical testing environment 
n•    Extensive experience in cGMP  as well as phase-appropriate cGMP compliance, method validation, and analytical method technology transfer.
n•    Experienced in the running of laboratories that cover chemical and bio-analytical techniques. 
n•    Broad industry experience encompassing production and laboratory operations
n•    Previous managerial experience in Quality (at least 5 years)
n•    Experience at an FDA regulated site an advantage.
n•    Excellent verbal and technical writing skills
n•    Plan project tasks effectively, prioritize, keep to timeline, and multi-task.
n•    Demonstrated ability to think independently, contribute and collaborate with cross functional project teams, troubleshoot effectively, and solve complex technical issues.

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Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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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.

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Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
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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.
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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 ****rel=no-follow>Privacy Policy .
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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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