Job description

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.
JOB SUMMARY
Responsible for overall project management, specifically in chemistry, manufacturing, and controls (CMC), for early to late phase product development. Provide PM leadership in the direction, initiation, planning, coordination, implementation, execution, control, and completion of specific CMC project(s) ensuring consistency with organizational strategy, commitments, and goals.

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

• In support of the Product Development Team Leader, provide leadership in the management of the CMC project team and program including subcontractor management.
• Execute on project strategy, priorities, and milestones ensuring visibility and accountability.
• Proactively lead with integrity and engage cross functional project teams and stakeholders.
• Create/maintain project scope, timelines, budgets, team, project plan and project objectives/goals.
• Proactively track and monitor project progress including financials, schedule, resource constraints, risks and opportunities, contract status, and other appropriate project performance indicators.
• Facilitate strategy discussions with CMC sub team and product development team members across multi-functional groups.
• Facilitate project meetings (to include minutes) and cascade key communications.
• Provide technical leadership to Emergent manufacturing sites and contract manufacturers in the resolution of technical issues.
• Provide project updates/reporting through program governance.
• Provide decision quality leadership through program governance and support across multi-functional groups.
• Lead collaborative alignment efforts with technical (process, product, analytical) development, production, quality, and regulatory stakeholders.
• Identify resource constraints and collaborate to resolve issues.
• Identify and risk assess critical path activities and work to support mitigation and resolution efforts with functional leaders.
• Provide leadership and support for inter-site best practices (technology transfer, process validation, etc.) and phase appropriate guidelines and policies.
• Support organizational / departmental initiatives.
• Prepare and conduct presentations to all levels of the organization which may include project technical and budgetary information.

To perform the job successfully, an individual should demonstrate the following competencies:

• Leadership – inspires and motivates others to perform well; effectively negotiates and 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, monitors, and delegates activities; provides recognition for results.
• Interpersonal – focuses on solving conflict, not blaming; maintains confidentiality; 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; 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.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Bachelor’s degree in field of biological sciences.
• 3 - 5 years project management experience, directly and independently managing projects through all phases of the project lifecycle, preferably in chemistry, manufacturing, and controls.
• Biopharmaceutical and manufacturing operations experience; preferably with familiarity/experience with technical transfer and qualification / validation activities to commercial licensure application.
• Knowledge and previous application of leading teams in regulatory submissions (such as IND, amendments, and BLA) is ideal.
• Previous experience managing subcontractors.
• Experience with Earned Value Management is ideal.
• PMP certification is ideal.
• Demonstrated ability to interact effectively with colleagues at all levels of the organization, including senior internal and/or external personnel on matters often requiring coordination between organizations.
• Strong leadership and facilitation skills; able to synthesize complex information into meaningful action to drive progress.
• Demonstrated high attention to detail.
• Fluent in project management tools (MS Project, SmartSheet).
• Demonstrated effective written and verbal communication skills.
• Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure.
• Ability to develop solutions to complex problems which require the use of ingenuity, innovation, and creativity.
• Self-starter, autonomous, motivated, and capable of working independently and multi-tasking.

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.
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.

jjbodyshop.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, jjbodyshop.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, jjbodyshop.com is the ideal place to find your next job.