Sr Manager, Technical Services
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POST DATE 4/2/2020
END DATE 4/11/2020
JOB DESCRIPTIONThose 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.
Reporting to the VP of Technical Operations, this position will work within the Technical Operations team. The role represents Emergent whilst leading multiple Technical Services initiatives in the oversight and monitoring of Product in CMO site(s) to ensure GMP, regulatory requirements and product specifications are being met. Additionally, the role involves the compilation of timelines, management of project budgets, completion of reports, help with regulatory filings and statistical analysis of data related to product quality, efficacy, safety in the support of product/process improvements and investigations etc. The position will require technical leadership, organization and management of delivery teams and subcontractors and will build and maintain effective and collaborative relationships with working teams within CMOs, executive management, and external customers.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
* Work as part of a team to manage assigned projects and schedules at CMOs as needed
* Build productive and collaborative relationships at the CMO facilities
* Initiate and build productive and collaborative relationships across Device Business Unit & supplier functions.
* Build effective and collaborative relationships with peers and executive management, as well as manage and communicate project progress, changes, issues and risks.
* Lead a series of Technical Services improvement projects which may include Regulatory, CMC-Drug and CMC-Device activities. Support the drafting of regulatory CMC documentation such as pharmaceutical development reports.
* Manage projects involving change management practices, scale up and testing of pharmaceutical dosage forms at third party manufacturers.
* Lead technical projects and provide the direction and technical leadership and management of all aspects of the teams and projects including subcontractor management.
* Works in partnership with in-house and CMO teams for the delivery of projects and on-going management of same.
* Lead product/process investigations at CMO s to ensure that issues (quality, manufacturing, design, regulatory) are thoroughly investigated, documented and closed with the appropriate corrective actions as the voice of the Device Business Unit.
* Develop and track goals, project plans, timelines and budgets.
* Track and monitor key performance indicators at CMOs.
* Execute spot audits at CMO s for adherence to GMP, SOP s and Regulations
* Establish and lead project core and sub-teams; facilitate discussions, team member conflicts and provide guidance/ direction on key technical project issues.
* Act as the project Technical Lead with customer, subcontractor counterparts and key internal stakeholders.
* Recognize and resolve fundamental and unanticipated technical issues.
* Influence decisions and exercise judgment to identify appropriate courses of action for obtaining results.
* Support Process Development, process characterization and capturing process knowledge to facilitate subsequent process validation and monitoring activities
* Ensure all appropriate documentation is in place at CMOs to support GMP, contractual agreements and compliance requirements in preparation for potential audits or inspections
* Set project strategy, priorities and milestones and lead project team with this vision and establish and maintain project timelines and Integrated Financial Plans.
* Develop, defend and manage project budgets coupled with an ability to manage and evolve as project needs change.
* Initiate and implement requirements for supplier controls and supplier process validation requirements at existing CMOs
* Regularly present to senior management and other key stakeholders in the form of project progress or update presentations.
* Complete Emergent and customer reporting requirements through dashboards and other updating tools.
* Develop and maintain project SharePoint site content.
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.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
* BS in Science, Engineering or similar discipline; an advanced degree in Science and/or Business is desirable.
* 5-7 years experience and a proven track record in the delivery of Technical Services projects within the device industry and/or an engineering background.
* Fluency in written and oral German highly desired
* Experience with medical devices, combination products, regulatory, quality and manufacturing required
* Experience managing and leading combination product or drug product teams required
* Must have good project management skills
* Strong written and oral communication skills required
* Must be able to perform in a fast-paced, fast growing environment with competing priorities under tight deadlines.
* Must be proficient in risk management practices and tools, having high expertise in process risk
* Must have a high proficiency in statistical methods and application and be able to apply appropriate statistical techniques to ensure the development of robust, predictive quality systems at CMO s
* Strong general understanding of pharmaceutical/ biotechnology industry required
* Must have effective critical thinking and problem-solving skills.
* Strong skills with Microsoft Office software including Visio, Word, Excel and Power Point are required.
PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.
The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical/Mental Demands and Work Environment Characteristics:
[In this section, check off the mental and physical requirements and work environment characteristics/occupational hazards of the job (as appropriate). Check only those that apply to the position as defined above.]
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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