Position Description: Manufacturing Director

Job Title | Manufacturing Director
Location | La Jolla, CA
Department | Operations

Summary

This position is responsible for managing all of the activities related to Manufacturing and develops departmental goals based upon corporate objectives.  The primary objectives are to direct the Manufacturing Department, so that quality products are manufactured on time and at or below budgeted costs, while adhering to all appropriate regulatory requirements and developing a trained and motivated staff. This position will manage the development and execution of the overall Department strategies.   Time is spent working with subordinates on the implementation of objectives and on their personal technical development. 

In addition to direct reports, this person will interact with personnel from all areas of the company but mostly with Director level and above. They will present alternatives and make recommendations. Will also keep management informed of progress on projects.

Essential Duties and Responsibilities

The duties and responsibilities of this position include the following, although other duties may be assigned.

• Responsible for meeting production requirements, yield and cost standards, through managers and supervisors.  Assists in assuring that products are manufactured according to cGMP.
• Responsible for ensuring that processes, equipment and the facility meet applicable Quality and Regulatory requirements.
• Represents the Manufacturing Department on multi-disciplinary teams and committees, such as CCB, MRB, Design Review, Training and MRPII.  Empowered to commit resources and recommend changes on behalf of Manufacturing.    Works closely with the Quality Group to determine quality policies and procedures, which affect the entire organization. 
• Develops strategy to maximize efficiencies, improve processes and create a productive team within the organization. Develops the Production plan with the Planning group, and establishes procedures for maintaining high quality standards to ensure that products conform to established customer and Company quality standards. 
• Directs, monitors and evaluates the performance of the Manufacturing Managers and Supervisors towards achieving the Company and their personal goals.  Acts as liaison between department management/subordinate levels, as well as executive/department manager levels to inform personnel of communications, decisions, policies and all matters that affect their performance, attitudes and results.
• Contributes to the development of the quality system, ensures that quality systems are followed, training is provided and corrective actions are completed through managers and supervisors.  Participates in audits by external agencies.
• Provides leadership and strategy in the hiring, development, motivation and performance review for the Department, including empowering managers and supervisors to make decisions and initiate actions.
• Administers annual department budgets and reviews actual results on a regular basis with managers and supervisors.
• Ensures that organization structure, resources, facilities and capital equipment are available to meet long-term production forecasts.

Supervisory Responsibilites

Manages up to 6 subordinate supervisors/ managers who supervise a total of 60 employees in the Manufacturing Department.  Is responsible for the overall direction, coordination, and evaluation of all areas of Manufacturing.  May also directly supervise non-supervisory employees.  Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Qualifications

Must have working knowledge of aseptic processes, environmental control,  and regulations related to pharmaceutical and device manufacturing.  Extensive knowledge and experience with aseptic facility design and QSR requirements. Must ensure processes and procedures adhere to Device (CDRH) and Biologics(CBER) requirements. Experience in validation of cleanrooms and processes.  Must have excellent organizational and communication skills for working with a broad spectrum of the company. Must be able to work under tight timelines and changing priorities.

• Technical Skills: Thorough understanding of Operation of clean rooms, Good Manufacturing Practices (GMP) and Quality System Regulations (QSR).  Good working knowledge of clean room practices, aseptic processing, environmental monitoring, fair labor practices, MRP II and budgeting skills.           
• Strong training and development skills: Able to develop managers to train supervisors.
• Strong communication skills (written & oral): For preparing reports and interacting with peers and presenting and interacting with upper management.
• Leadership skills:  Delegate, develop and motivate personnel; provide appropriate level of training for personnel within group and interact professionally and maturely in difficult situations.
• Analytical skills:  Able to analyze complex situations/data and make recommendations for actions.  Able to train others to initiate and perform failure investigations relating to job responsibilities and manufacturing processes. 
• Planning/Organizational Skills:  Able to take an objective or goal, determine all of the tasks and milestones required to meet the goal and organize the tasks with achievable timelines and within acceptable standards.  Experienced in developing budgets.  A detail oriented person that can conceive, research, target and control reductions in cost and product lead times on both existing and new products.  An energetic problem solver with the ability to hire, manage and motivate a workforce.
• Implementation Skills:  Able to develop broad goals and objectives and translate them into achievable milestones and action plans.  Possess the capability to follow through with assignments and capable of leading others to do the same.  Able to administer and facilitate change.  Strong background and skills in process improvement.
• People Management Skills:  Good organizational, problem solving, communication and negotiating capabilities.  Able to adapt and administer change.

Education and Experience

Bachelor's degree (B. A.) from four-year college or university, and more than 10 years related experience and/or training; or equivalent combination of education and experience.  Master's degree (M. A.) or additional certification preferred. 

Language Skills

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents, professional journals, technical procedures, or governmental regulations.  Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.  Ability to write reports, business correspondence, and procedure manuals Ability to effectively present information to top management, clients, customers, and the general public, and/or boards of directors.

Mathematical Skills

Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.  Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

All qualified resumes should be submitted directly to careers@abh.com

We are an Equal Opportunity Employer.