1+ months

Drug Substance Upstream Supervisor/

Pfizer
Hangzhou (tier 2)
**** **Role Summary**

SOPGMP/Lean6SME/SME

Responsible for the successful management of Manufacturing Operations groups of drug substance Upstream. Work with DS Production Manager to establish departmental goals, objectives, staffing and operational budgets, creates and aligns the strategy and objectives with the OpU. Ensures compliance with Standard Operating Procedures (SOP), current Good Manufacturing Practice regulations (GMP), corporate policies and safety practices. Oversees all Manufacturing/ projects and initiatives in DS Upstream, is responsible for ensuring that the operational excellence tools such as Lean manufacturing and Six-Sigma are used to drive continuous improvement. Participate in the execution of pharmaceutical manufacturing processes, provide guidance as an DS Upstream SME and managing the operations, including suite clearance and changeover, equipment processing, formulation, manufacturing batch record review. Use operational and technical expertise to assist in troubleshooting activities, technology transfer and start-up activities. Provide investigations support, analyze process data and identify and implement process improvements. As an DS Upstream SME, design, specify, and purchase new or modified equipment based on technology innovation and process needs. Author, review, approve and present comprehensive technical presentations, procedures, policies and processing instructions.

**** **Role Responsibilities**



+ **** **Organizational Leadership**



+ cGMP



Responsible for the successful operation of the DS Upstream. Create the strategy to meet the Business Goals. Directs the efforts of management staff responsible for the production of the product or completion of the process in compliance with all regulatory requirements, cGMPs and company policies, procedures and goals.



+ EHS



Assures the appropriate interaction with Quality, Drug Product Production, Technical Service, Engineering & Maintenance, Supply Chain, Training, BT, Finance, Environmental Health & Safety and Human Resources/ Labor Relations.



+



Procedures - Establishes procedures, and directives for DS Upstream .



+



Provide local execution support during CTA lot execution at CROs/CMOs.



+ **** **Compliance & Quality**



+ SOPMBR



Oversees and ensures the implementation of company policies, site specific guidelines and relevant SOPs within department. Review before approval to ensure the integrity and accuracy of MBR.



+ cGMPEnsures that cGMP and safety training for all staff within department is conducted in a timely, efficient and complete.

+ cGMPEnsures operations are in compliance with company standards as well as country and local regulations including; cGMPetc.

+ Author, review, and approve documentation such as batch records, procedures, and validation reports.

+ DSManage the DS Upsteam team through the training, operations, performance etc.



+ **** **Process Improvement**



+ Develops and implements strategic direction for process improvements.

+ Executes production performance on time and within budget.

+ ( ) Engages all department employees in the continuous improvement process right down to shop floor personnel.

+ Cultivates a culture of continuous improvement.



+ **** **Financial**



+



Work with DS Production Manager to d evelop DS Upstream operating budgets , labor and capital expenditures that are consistent with short and long-term budget.



+ Drives cost improving projects.



+ **** **Talent Management**



+



Coaches employees on a timely basis regarding performance (behavior, skills and attitude) to form a high performance team. Oversees in the recruitment, selection, promotion, termination and performance management of staff. Identifies development opportunities for staff and prepares staff for future promotional needs.



+



Actively participates in succession planning to ensure dept maintains flexibility and the ability to quickly respond to changes.



+



Responsible for overall performance and salary recommendations for DS Upstream .



+



Meets with cross-functional management staff to evaluate production process needs, resolve problems and obstacles, provide resources, reset direction and maximize effective interactions and functioning. Works with support groups to develop priorities and strategies for completing cross- functional assignments to meet department goals and initiatives.



+ **** **Planning**



+



Work with DS Production Manager to develop long-term strategic plans for the department, including capital needs, labor resource needs, and facility improvement needs to meet long range production forecasts.



+ Designs, develops and evaluates department plans. Be responsible for plan execution of all tasks needed to achieve both routine and stretch goals.



**** **Qualification ( Minimum Requirements)**



+



Bachelor degree or above in pharmacy, chemical engineering, biology, biochemistry or other related science or equivalent.



+ 3 / GMP 1



At least 3 years hands-on experience in quality/operation work in pharmaceutical industries, familiar with the GMP management, and over 1 year experience in management.



+ cGMP



Familiar with the regulatory requirement and standards in Pharmaceutical industries, and cGMP standard (local & international).



+



Familiarity and experience with mammalian cell culture. Experience with manufacturing-scale bioreactors centrifuge as a plus.



+ 6 1 5S



Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs is a plus.



+



A responsible, proactive team player with high initiative also strong leadership, good interpersonal, communication and problem solving skills is required.



+ MS



Fluent in English (spoken and written), and good computer operation skills (MS office software, etc.)



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Categories

Posted: 2019-11-07 Expires: 2020-03-11

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Drug Substance Upstream Supervisor/

Pfizer
Hangzhou (tier 2)

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