Manager, Manufacturing - Central Services

Manager, Manufacturing - Central Services

Manager, Manufacturing - Central Services


Department: Manufacturing
Location: Smithfield RI
Job Code: 522




Description


Alexion Pharmaceuticals, Inc.



Job Title(Alexion-English) :
Manager, Manufacturing – Central Services

Job Title(Local) :
Manager, Manufacturing – Central Services

Function:
Manufacturing



Location:
Smithfield, RI
Relocation
Covered

Reports to:
(Job Title of strong line)
Associate Director, Purification & Central Services
Reports to:
(Job Title of dotted line)
N/A





The Manager has direct line responsibility for the weigh/dispense, solution preparation and equipment preparation functional areas in a 24/7 manufacturing facility for commercial manufacturing of biopharmaceuticals. This position will serve as a subject matter expert during regulatory inspections and be accountable for maintaining an inspection-ready operation at all times. Additionally, the position will be responsible for cross-functional collaboration with other departments within Alexion Pharmaceuticals, Inc. to support company goals and site metrics.







Principal Accountabilities




Develop, implement and monitor departmental objectives and schedules including setting priorities and performance expectations while ensuring alignment with expected deliverables, site metrics, and company goals

Manage and develop a staff of 11 full time associates, 9 temporary associates, and 4 supervisors

Manage staff to project timelines effectively while ensuring clear and concise communication to plant management

Effectively manage data entry into the enterprise resource planning database to maintain a compliant trace of all raw materials, solutions and consumable items used in the manufacturing process

As appropriate, coordinate and lead deviation, change control and process improvements for area of responsibility, identify root causes and implement appropriate corrective and preventive actions to prevent repeated occurrences

Serve as subject matter expert for regulatory inspections, and collaborate with plant management to address any follow-up responses or corrective actions

Ensure effective interactions with other departments and customer representatives as appropriate to support site metrics

Effectively recruit and develop staff in accordance with company policies in support of effective succession planning

Develop and manage portions of the departmental budget and spending in support of department objectives for cost control while maintaining effectiveness


Major Skills(technical know-how, language, Computer Literacy):






Strong working knowledge of cGMP manufacturing operations and ability to maintain regulatory requirements for compliance at all times
Proficient

Comprehensive understanding of logistics constraints of operating large scale equipment in a commercial manufacturing plant, under a rigorous production schedule
Proficient

Must have excellent written, verbal, and presentation skills with a demonstrated ability to work effectively in a fast-paced team environment
Proficient

Comprehensive understanding of stakeholders’ needs and strong decision making ability to shift central services schedule accordingly to meet stakeholder’s needs
Proficient

Language
Level

Must be able to speak English as a first language
Proficient

Computer Literacy
Level

Must have good working knowledge of MS Excel, Word, Powerpoint, and Project
Proficient

Competencies



Job-related
People Management
Other

Demonstrated ability to lead a team of manufacturing staff through successful cGMP inspections by internal auditors and external agencies, while ensuring a high degree of compliance
Demonstrated ability to organize and lead manufacturing operations on a campaign and continuous basis, to develop leaders in the organization, and to provide opportunities for staff to grow


Ability to inspire, organize and lead continuous improvement efforts within central services manufacturing operations and participate in site-wide continuous improvement efforts
Demonstrated ability to promote a positive work environment by effectively administering company policies and procedures, maintaining a satisfactory safety record for the department, and monitoring performance management in line with HR policy.



Skills
Education:



BA/BS in Biology, Chemistry, Chemical Engineering or related discipline


Work Experience:



8+ years commercial biopharmaceutical cGMP management, significant experience within a large scale (10,000 L) manufacturing facility

Internal and External Relationships
List which internal and external customers/contacts are expected within this job.



Quality Assurance, Technical and Clinical Manufacturing Services, Logistics, Quality Control, Validation, Automation, Human Resources, Metrology, Vendor Representatives, Contractors