* Daily supervising and performing on-the-floor operations pertaining to biologics manufacture in a cGMP environment
* Coaching, counselling, training/development, discipline and recognition of direct staff, including performing annual performance reviews
* Generating SOPs, MPRs, and SPRs for equipment and procedures used in routine biologics manufacture.
* Executing production and resource schedule against operational plan
* Ensuring performance of all process steps specific to the phase or stage of operation (e.g. upstream, downstream, support)
* Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements
* Final review of completed manufacturing documentation per compliance standards and established timelines
* Investigating and resolving problems, identifying root cause, and proposing process improvements through clear communication to senior management
* Interacting with outside vendors and senior management
* Participation and/or leadership role in multi-functional project teams, as necessary
* Participate in helping to evaluate and establish potential new interdepartmental procedures and practices
* Other duties as assigned or identified
* Majority of liaison is on internal basis with subordinates and supervisors at equivalent level or one level higher
* Liaison normally involves specific phases of a project or operation
* Contacts with outside vendors and senior management are infrequent and involve routine matters
* 5-7 years work experience in pilot or commercial biologics manufacturing under cGMP with Bachelors. 3-5 years experience with Masters degree. 10-15 years experience with Associates Degree and 15+ years experience with High School education.
* BS/BA degree preferred in biological sciences or biotechnology/life sciences. Masters degree accepted.
* Associates and High School Diploma acceptable with appropriate experience
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation
Additional NotesMonitors daily operations of a unit and actively assists, or provides direction to, subordinates as required
May perform, especially in staff or professional groups, ongoing operational tasks of organizational unit
Strong Situational Leadership skills and capabilities
Good organizational skills
Proven success leading teams of approximately ten employees and ability to coach, mentor, and develop team members to meet future needs of the organization
Strong collaboration and communication skills
Position CategoryManufacturing and Production
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MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer