长沙招聘

POSITION RESPONSIBILITIES

Organizational Leadership:

· Responsible for the successful operation of the Dept. Creates 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.

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

· Procedures - Establishes procedures, and directives for the dept.

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

· Lead execution of DS startup/scaleup/clinical lots production in new facility.

Compliance & Quality:

· 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.

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

· Ensures operations are in compliance with company standards as well as country and local regulations including; cGMP，etc.

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

· Manage the DS 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:

· Develops operating budgets , labor and capital expenditures that are consistent with short and long-term budget.

· Drives cost improving projects.

· Budget preparation for department programs and processes including headcount and capital expenses. Minimize unnecessary costs and inefficiencies.

· Develops capital plan to support business needs. Authorizes purchase orders for equipment, services and supplies. Develops Annual Business Plan for the dept – Shared Decision with site leader/Finance

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 the group.

· 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：

· Working with functional department heads, develops 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.

EDUCATION AND EXPERIENCE QUALIFICATION

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

· At least 5~8 years hands-on experience in quality/operation work in pharmaceutical industries, familiar with the GMP management, and over 3 year experience in management.

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

· Familiarity and experience with mammalian cell culture, protein purification and/or solution formulation is highly desirable. Experience with manufacturing-scale bioreactors centrifuge, column chromatography and/or tangential flow filtration (UF/DF) a plus

· 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.

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