Senior Manager of Operations
Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
Summary Production Operations is responsible for the preparation of all components and equipment used in the sterile filling process, conducting the sterile filling processes, the decontamination of sterile filling equipment, and the sanitation and preparation of the processing facilities. Production Operations accounts for 70% of the site staff and spend.
This position is responsible for approximately 90% of the total site revenue, approximately 70% of the site spend, all customer interactions for their specific product line, equipment and assets, as well as all day-to-day and strategic manufacturing operations for a 24x7 operation. This position will be part of the extended site leadership team.
The Director is responsible for the tactical and strategic management of manufacturing operations and personnel. This encompasses planning, coordinating, and supervising manufacturing in accordance with delivery dates, customer specifications, established quality standards and meeting all FDA and international regulatory and customer requirements. The Director is responsible for all Primary Manufacturing Operations at Albuquerque including compounding, Wash & Prep, Glass Prep, short-range production scheduling, sanitation, sterilization, and sterile filling. The Director supports the Quality Assurance Product Specialists and Customer Service Representatives for direct customer contact.
The Director is responsible for managing a team of approximately 145 hourly technicians, 5 shift managers, 5 supervisors, 3 Senior Specialists and 3 supervisors in training. Also responsible for the training dept. and Sterile University. The position is responsible for all aspects of producing product for the three lines in the facility. The Director is responsible for developing and implementing metrics to evaluate the performance of the manufacturing operations. The Director is responsible for the training and development of the aseptic filling team including management, hourly and supervisory personnel. The Director is also responsible for integration of 6-Sigma and LEAN manufacturing into the organization.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Performs the usual duties of a Director such as developing and managing budget and performance objectives, scheduling, hiring, timecards, performance evaluation, termination, etc.
Provides oversight of the employees and functions of the Production Operations areas in the preparation of equipment and components to be used in the filling process and the completion of the sterile filling process.
Reviews and approves discrepancy reports to effect release of product.
Leads, attends and participates in meetings that affect release of product and schedule planning.
Works on projects to analyze and improve manufacturing process; writing SOP’s and documenting project.
Ensures proper training of staff and appropriate records of training have been kept.
Directly and through staff (three Shift managers, six supervisors and 3 supervisors in training) ensure cleanliness of assigned areas, sanitation of clean rooms, sterilization of filling equipment, the wash and prep of filling equipment, the preparation of vials and ampoules, and the completion of the sterile filling process.
Directly and through staff understands and implements safety procedures and cGMP.
Responsible for the training and development of the supervisory staff.
Directly and through staff, responsible for customer interactions for scheduling, forecasting, issue resolution.
Bachelor’s degree in Engineering, Business, Manufacturing, one of the sciences or equivalent relevant education and experience. Five years directly related experience in pharmaceutical industry or equivalent relevant education and experience. 10 years’ experience preferred.
To perform the job successfully, an individual should demonstrate the following competencies:
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
Design - Generates creative solutions; Demonstrates attention to detail.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities.
Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
Visionary Leadership - Displays passion and optimism; Inspires respect and trust; mobilizes others to fulfill the vision; Provides vision and inspiration to peers and subordinates.
Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
Delegation - Delegates work assignments; Matches the responsibility to the person; Gives authority to work independently; Sets expectations and monitors delegated activities; Provides recognition for results.
Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self-available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.
Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals.
Cost Consciousness - Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.
Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; Builds a diverse workforce.
Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
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.
To perform this job successfully, an individual should have knowledge of Manufacturing software; Spreadsheet software and Word Processing software.
Certificates, Licenses, Registrations
Other Skills and Abilities
Proven leadership and supervisory skills,
Proven personnel development skills.
Proven communication skills both verbal and written.
Proven analytical and organizational skills.
Proven problem -solving skills.
Proven initiative and self-starter skills.
Other Qualifications/ Responsibilities
The Director of Manufacturing:
Coordinates all production activities with support services.
Is part of the extended leadership team for the site
Interfaces with Director and managers of Quality Assurance, Microbiology, and Engineering.
Conducts and supervises investigations of deviations and unusual events.
Conducts weekly multi-department operational meetings.
Has responsibility for the performance of assigned departments which impacts all production revenues for company.
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk and sit. The employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts; fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to high, precarious places; extreme cold; extreme heat; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.