Why Join Societal CDMO?
Mission and Culture:
Each day we Bring Science to Society as we work towards improving the quality of life for patients who benefit from the therapies that we manufacture. We strongly believe that every employee plays an impactful role in accomplishing our mission of improving patients’ lives through client partnerships. Whether you are working hands-on in developing, manufacturing, or, testing the products or if you are utilizing your expertise in any other way, through your work here you will have an opportunity to positively affect countless lives.
We foster a culture that is diverse, inclusive, challenging, and supportive. At Societal, we are committed to continuous improvement both as individuals and as an organization. We encourage our employees to continue their personal and professional development in various ways.
Your New Role At Societal:
We are looking for a Director of Manufacturing Operations. In this role, you are accountable and responsible for management of the Manufacturing department at the San Diego, California facility. This is a leadership role with focus on the start-up and execution of GMP operations for all production areas, ensuring the facility is properly staffed, trained and flexible to meet the needs of Societal’s Clients. They ensure departmental cGMP and regulatory compliance, good internal and external customer service, cost monitoring / control, and employee training and development. They work collaboratively with other function heads to implement overall site and company objectives. They are also responsible to manage supervisory and technical staff in their efforts to hire, schedule, train personnel and perform their responsibilities effectively. They will also represent the organization in customer interactions involving sales, deviation management and technical trouble shooting.
How You Will Make An Impact:
Provides leadership, vision, and management to the Manufacturing team. Establishes and communicates high performance standards, defines clear accountability, and leads by adopting improvements strategies to reduce operational variances, and increase efficiency.
Ensure compliance with cGMPs and other established procedures and regulations.
Ensures timely and quality delivery of clinical supplies that meets customer study protocol, regulatory, and budgetary requirements.
Partner with Planning regarding the development of the manufacturing schedules and ensure adherence to the manufacturing schedule.
Partners with Project Management to implement new production processes. Processes may include, but are not limited to, formulation, aseptic filling, lyophilization, and finished product labels and cartons.
Builds effective partnerships with department heads to help drive the business towards achieving company objectives.
Participate in the growth of the site with respect to new products. Provides strategic recommendations for advancement in technology, compliance, and efficiencies.
Preparation of monthly and other reports for the Operations & Site Head.
Participate in process investigations, manufacturing equipment qualification, process validation activities, and internal audits of operational areas.
Establishment, revision and approval of procedures, batch records, policies, and reports relating to Manufacturing. Identifies gaps in SOPs and makes appropriate mitigation recommendations to ensure global compliance. Helps guide and develop new functional SOPs, as necessary.
Establish guidelines to ensure safe work areas and practices and ensure adherence to all SOPs, Safety and Company policies.
Rapidly and accurately communicates issues to Senior Leadership. Resolves manufacturing and facility issues to mitigate any supply disruptions
Active participation in Operational Excellence program, and other site initiatives.
Communicate to and co-ordinate operational activities with appropriate planners, controllers, and department supervisory personnel to ensure alignment of priorities and issues.
Provide strategic direction for Manufacturing
Leadership Responsibilities
Supports a diverse and inclusive culture and workforce, ensures compliance with laws, regulations, and company policies
Identifies, recruits, and retains top-notch talent.
Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance management.
Develop employees to meet both their career and organizational goals
Builds strong customer relationships and delivers customer-centric solutions.
Maintains transparent communication, appropriately communicates organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication.
Comfortable working in ambiguous situations and adaptable to change
Must model the highest degree of moral and ethical behavior and maintain confidential information
High degree of autonomy and strong decision-making skills
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