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25 days old

Manufacturing/Production Manager/Director (Pharmaceutical) - Chandler, AZ

Kelly Services
Chandler, AZ 85286
**Manufacturing/Production Manager/Director (Pharmaceutical) - Chandler, AZ**



Kelly Scientific has an exciting opportunity for a **Manufacturing/Production Manager/Director** to work with one of our top clients in Chandler, AZ.



This is a Direct Hire opportunity, working with a new and upcoming Start Up! Must hve Pharmacetuical GMP experience!



Will consider candidates who are looking to relocate to Arizona.



**Summary:**



Responsible for management of all aseptic manufacturing operations of drug product including the compounding, filling, and inspection under cGMP regulations in a highly complex and compliant start up environment. Incumbent will provide leadership and execution in support of business objectives for all drug product manufacturing activities. The incumbent will also ensure all manufacturing technicians are trained and qualified in aseptic technique.



Incumbent will lead a team of manufacturing professionals to ensure delivery of results by meeting the production schedules and critical deadlines, and identifying and implementing continuous process improvements that improve operational efficiency and quality performance



**Duties and Responsibilities:**




+ Leads and manages the drug product manufacturing team to achieve compounding, filling and inspection goals and objectives.

+ Responsible for training and qualifying all manufacturing technicians in aseptic technique to ensure sterility requirements are met.

+ Manages compounding, filling, and inspection production scheduling and capacity analysis to ensure product is manufactured and inspected such that it can be released within schedule.

+ Provides technical leadership for compounding, filling, and inspection

+ Supports technology transfer, media fills, and process validation activities in close collaboration with QA and QC.

+ Oversees, either directly or indirectly, investigations and process deviations relating to manufacturing.

+ Leads and oversees scheduling activities for all manufacturing activities including commercial production, product development, transfer and validation

+ Responsible for the development of production schedule, communication of requirements and supplies needed for production, and scheduling of employees to execute the production schedule.

+ Manages technical and process changes in close collaboration with quality, regulatory and other involved functions.

+ Resolves any drug product manufacturing related issues.

+ Provides functional leadership of drug product manufacturing including compounding, filling and inspection. Leads and develops the production team and ensures that the right skills and capabilities of people are developed to enable the organization to be flexible/adapt to the dynamic business conditions.

+ Develops and supports a high performing production department with accountability for talent acquisition, talent management, engagement, training, safety, and compliance.

+ Ensures staff compliance with all applicable quality, compliance, safety, GMP, and regulatory standards at all times.

+ Ensures staff is sufficiently trained to perform their job responsibilities, SOPs, cGMP and EHS accountabilities.

+ Develops an organizational structure that will adequately manage the function's responsibilities.

+ Supports new product development/implementation including process transfers, launch and manufacturing of Drug Products. This includes providing technological support, supporting the technical project phase, process transfer, validation, trouble-shooting activities and regulatory filing activities.

+ Monitors and analyzes performance of drug product manufacturing processes to ensure process validation, continuous process improvement, trouble shooting, and deviation investigation and resolution for Drug Products.

+ Leads and is accountable for the cost center budget for the production department.

+ Ensure compliance with all manufacturing processes in accordance with Government (cGMP, FDA, DEA, OSHA, Safety) and Company Policies, Procedures, Goals and Objectives.

+ Follow and ensure compliance with all relevant department policies, procedures, SOP and other requirements during manufacturing execution and act at all times within the organizations standards/ethics policies. Strong understanding and appreciation for regulatory requirements and compliance standards.

+ Coordination and communication between multiple departments, including leadership, QA, and QC



**Minimum Requirements:**




+ Bachelors degree from an accredited institution (in engineering, biotechnology, or biological / pharmaceutical sciences) plus four (4) years of expertise in drug product manufacturing.

+ Three (3) years of leadership/management experience required with demonstrated ability to set vision and direction for a team including setting expectations and motivating for results.

+ Management experience in achieving results and managing others to achieve corporate, site, and departmental objectives, an excellent collaborator.

+ Experience leading manufacturing teams to maintain adherence to a demanding production schedule, working with cross-functional teams, such as Quality, Facilities, Engineering, and Validation.

+ Broad experience in pharmaceutical manufacturing and/or packaging of sterile drug products, and a proven track record solving complex technical issues.

+ Experience with authoring and reviewing standard operating procedures, on-the-job-training, and other controlled documents

+ Experience with Quality Systems such as Deviation, CAPA, Change Control Systems required

+ Experience in troubleshooting, investigation, root cause and risk analysis in a cGMP environment required.

+ Experience leading the implementation of technical and continues process improvements

+ Experience in the establishment of safe practices in a cGMP environment required including expertise and knowledge in GMP manufacturing

+ Excellent communication skills, good presentation and influencing skills and the ability to interact and gain the support of senior management

+ Skilled in communication and negotiation fast decision making to ensure the daily business.

+ Excellent leadership, communication and collaboration skills in a cross-functional and fast paced environment



**For immediate consideration apply Today! Questions? Call Kevin at 623-688-2142 email at kevin.lau@kellyscientific.com**






**Why Kelly** **** **?**



Kelly Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-07-13 Expires: 2020-08-13

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Manufacturing/Production Manager/Director (Pharmaceutical) - Chandler, AZ

Kelly Services
Chandler, AZ 85286

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