1+ months

Sr Manager, Technical Services

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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.

Oversee the development and lifecycle management of processes and production of small molecule drug substance and drug product candidates. This activity includes medicinal chemistry preparation of potential candidates, product scale-up, process optimization, technology transfer, analytical data interpretation, process validation activities and manufacturing support . Provide technical expertise to external vendors or CMOs to deliver projects exiting from the R&D space that need to be successfully deployed into a commercial setting and projects that involve lifecycle management or process improvements that addresses COGS, product-output or cGMP concerns.

Essential Functions

  • Accountable for end-to-end technical support of Externally Manufactured Products to ensure on time product supply.
  • Collaborate with key stakeholders, suppliers, and customers to ensure processes are reliable and meet Operational needs.
  • Establish partnerships with vital stakeholder departments to ensure timely sharing of information and a collaborative approach to problem solving and process improvement and the application of lean manufacturing techniques to continuously improve cycle times and process flows.
  • Review and provide strategic input to process-related investigations, product impact assessments, Change Control assessments, CAPA completion and raw material changes.
  • Offer subject matter expertise as a reviewer of project plans, technical reports/studies related to process understanding, regulatory submissions, and Validation protocols.
  • Provide technical support for investigations and lend expertise in problem solving activities on existing production activities, determining root cause and corrective actions.
  • Responsible for providing technical support to Contract Manufacturing Organizations for drug substance, drug product formulation development, product scale-up, process optimization, technology transfer and process validation activities and manufacturing support.
  • Identifying appropriate equipment to manufacture candidate molecules and drug products at contract manufacturing organizations
  • Preparation and review of experimental protocols and reports, including documentation such as Technology Development Reports, Technology Transfer Protocols, stability protocols and Manufacturing Batch Records.
  • Communicate ideas and experimental designs for multiple projects with colleagues and managers; responsible for writing and presenting monthly, quarterly, and annual reports Additionally, author internal status reports and presentations to team and senior management on a regular basis
  • Monitor and communicate progress and budget and highlight delays or potential risks to project timelines

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.


To perform the job successfully, an individual should demonstrate the following competencies:
Teamwork Balances team and individual responsibilities; Contributes to sustaining a positive team spirit; Puts success of team above own interests; Contributes positively to team morale and commitments to broader goals and objectives; actively participates in dialogue and expands understanding of goals.
Problem Solving Identifies and resolves problems in a timely manner, analyzing information skillfully; Develops alternative recommendations and 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.
Leadership Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Inspires respect and trust; Accepts feedback from others; Contributes to vision, encourages and inspires peers; Gives appropriate recognition to others.
Business Acumen and Ownership Considers business implications of recommendations and decisions, seeks input for same; Aligns work with strategic goals; Works within approved budge; Develops and implements cost saving measures; Conserves organizational resources.

Education, Experience & Skills

  • Higher degree in Chemistry (Organic Chemistry/Medicinal Chemistry) required, with 7 plus years of related industry experience in drug substance and drug product manufacturing.
  • Extensive knowledge of synthetic and analytical operations specifically involving medicinal chemistry, process chemistry, and manufacturing.
  • Demonstrated experience managing Contract Manufacturing Organizations.
  • Knowledge of late-stage development including pre-validation activities (small scale manufacturing model qualification, process optimization, risk-based approach to FMEA, process characterization). Matrix based experimental design is required and experience with DOE highly desirable.
  • Knowledge of ICH guidelines including Q7, Q8, Q9, and Q11 and US FDA process validation guidelines.
  • Experience working with US Government contracting an advantage
  • Experience with Project Management tools an advantage

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 actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe 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.

Industry

  • Biotechnology
Posted: 2022-07-29 Expires: 2022-09-29

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Sr Manager, Technical Services

Emergent BioSolutions Inc.
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