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Title

Sr. Director, Manufacturing Operations 

Category Manufacturing  
Description

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

 
Position Requirements

Ideal Candidate Will Bring:

Bachelor’s degree in business technical or science related field required.

Fifteen years of work experience in a manufacturing industry, at least 10 years within a pharmaceutical manufacturing environment, preferably in solid oral dose products.

Minimum of 8 years of direct people management experience is required.

Aseptic filling and lyophilization experience is highly preferred.

Knowledge/Skills/Abilities

Strong understanding of cGMPs and other regulatory guidelines applicable to pharmaceutical industry.

Extensive knowledge of processes and technical parameters related to the development of pharmaceutical products and the transfer to commercial production processes.

Ability to manage multiple priorities in a manufacturing environment.

Strong professional writing skills and ability to prepare technical reports.

Demonstrated interpersonal and leadership skills with the ability to interact with other departments and effectively and efficiently lead others in a team environment.

Solid working knowledge of MS Office (Word, Excel, PowerPoint, Access, Outlook), Internet.  Strongly prefer prior experience using an enterprise resource planning software such as SAP.

Ability to explain difficult concepts and persuade others to adopt a point of view.

Ability to make decisions – guided by policies, procedures, and technical knowledge – that impact the company’s ability to meet performance objectives.

Benefits:

For applicants based in California:

The California base pay rage for this position is estimated to be $152,000-$195,000. The base pay offered may vary or fall outside of the range provided, depending on multiple individualized factors including but not limited to candidate’s job-related qualifications, internal equity, market data and geographic location.

At Societal, we offer a diverse and competitive total rewards package to attract and retain talent.  In addition to base compensation, all employees are eligible for one of our annual performance opportunities (bonus or commission) and equity-based long-term incentive. In addition, we offer a wide range of benefits including medical, dental, vision, paid time off, paid company shutdowns and holidays, 401k matching, life insurance, paid parental leave and much more.

Who is Societal:

Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client’s needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry-leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging, and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California, and Gainesville, GA.

If you would like to apply for this position, please visit our website at www.societalcdmo.com and click on the "Careers" section.

New hires will pass a background check, and drug screen and will be required to show proof of COVID vaccination (subject to limited qualified exemptions) as a condition of employment.

We are an EOE dedicated to a diverse workforce and a Drug-Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law.   If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.

 
About the Organization Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia.

New hires will pass a background check and drug screen as a condition of employment.  
EOE Statement We are an EOE dedicated to a diverse workforce and a Drug-Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law. If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.  
EmpID None Specified 


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