Paladin Labs Inc.
Director, Aseptic Operations - Sterile Fill
Paladin Labs Inc., Rochester, Michigan, us, 48308
* Directs production in Sanitation, Preparation Services, Drug & Chemical Dispensing, Bulk Manufacturing, Sterile Filling, Inspection & Packaging.* Oversees execution of commercial production to meet patient, quality, business, and financial objectives as well as supporting developmental and technical transfer production activities across three shifts.* Maintains proper staffing and training levels to meet requirements.* Provides management reporting through development and use of department metrics aligned with Site Objectives and Scorecard.* Sets priorities to meet internal cycle times and delivery schedules.* Assure adequate maintenance of department machinery and supplies.* Establishes and drives expectations for production schedules & reducing non-value-added waste while meeting weekly delivery schedule and financial objectives.* Participates and develops long-term strategies and risk management programs that increase the compliance, efficiency and effectiveness of operations* Develops and maintains a safe manufacturing environment in accordance with plant/corporate policies and with local, state and federal environmental, health and safety regulations.
Participates in safety meetings, investigates accidents, expects proper PPE and industrial hygiene controls, and takes appropriate corrective actions to eliminate hazardous conditions.* Promotes a quality and compliance focused culture which embraces RFT (right first time) and CI (continuous improvement)* Assures cGMP compliance with regulatory agencies (FDA, EMA, etc.)* Performs assessments and risk assessments based on business development and new product/process/technical transfer activities associated with employee operations, GMP Compliance and safety.* Lead initiatives for root cause analysis to implement effective corrective actions, reducing the potential for deviations related to human error.* Manage audits and inspections by regulators, corporate office and contract customers by escorting and facilitating information sharing, document review and response commitments.* Directs change controls related to processes, equipment, documentation and safety practices in accordance with Quality System requirements.* Establishes expectations, drives accountability & influences effective team building and team work.* Creates an atmosphere of team effort, open communication and inspirational shop floor management.* Interacts productively with peers across all site work streams.* Leads operations managers, supervisors, and hourly staff.* Develops cooperative relationships with contractual bargaining agreement leadership team and colleagues* Meets site objectives in compliance, quality, transformation, employee learning & development, and financial areas.* Supports capital planning initiatives to ensure site remains compliant with local, state and federal requirements.* Sponsors Operational Excellence Program (OEP) improvements as development opportunities for all staff.* Manages special projects as requested/assigned by Executive Team.* Direct parenteral manufacturing/quality experience preferred.* Bachelors/Master's degree from an accredited college or university with a major in Science, Packaging Engineering or Business* Six-ten years of progressively responsible work-related experience designing, customizing, managing and evaluating manufacturing operations inclusive of programs to support ongoing personnel development.* Minimum of 10 years supervisory/leadership experience with specific involvement with Operations, Quality and/or Compliance Management.
Emphasis on team building, problem solving and employee development inclusive of succession planning.* High level of proficiency in adult education and training, and group presentation* Must be familiar with different approaches to staff and management development using various delivery systems* Skilled in relational databases and ability to use computerized software to support management reporting including word processing, spreadsheets, charts/graphs and presentations* **Managing People** - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes oneself 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.* **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.* **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.* **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. Excellent communication skills, including the ability to speak clearly and persuasively in all situations, listen and gain clarification, respond well to questions and write clearly and informatively* **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.* **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.* **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.* **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 #J-18808-Ljbffr
Participates in safety meetings, investigates accidents, expects proper PPE and industrial hygiene controls, and takes appropriate corrective actions to eliminate hazardous conditions.* Promotes a quality and compliance focused culture which embraces RFT (right first time) and CI (continuous improvement)* Assures cGMP compliance with regulatory agencies (FDA, EMA, etc.)* Performs assessments and risk assessments based on business development and new product/process/technical transfer activities associated with employee operations, GMP Compliance and safety.* Lead initiatives for root cause analysis to implement effective corrective actions, reducing the potential for deviations related to human error.* Manage audits and inspections by regulators, corporate office and contract customers by escorting and facilitating information sharing, document review and response commitments.* Directs change controls related to processes, equipment, documentation and safety practices in accordance with Quality System requirements.* Establishes expectations, drives accountability & influences effective team building and team work.* Creates an atmosphere of team effort, open communication and inspirational shop floor management.* Interacts productively with peers across all site work streams.* Leads operations managers, supervisors, and hourly staff.* Develops cooperative relationships with contractual bargaining agreement leadership team and colleagues* Meets site objectives in compliance, quality, transformation, employee learning & development, and financial areas.* Supports capital planning initiatives to ensure site remains compliant with local, state and federal requirements.* Sponsors Operational Excellence Program (OEP) improvements as development opportunities for all staff.* Manages special projects as requested/assigned by Executive Team.* Direct parenteral manufacturing/quality experience preferred.* Bachelors/Master's degree from an accredited college or university with a major in Science, Packaging Engineering or Business* Six-ten years of progressively responsible work-related experience designing, customizing, managing and evaluating manufacturing operations inclusive of programs to support ongoing personnel development.* Minimum of 10 years supervisory/leadership experience with specific involvement with Operations, Quality and/or Compliance Management.
Emphasis on team building, problem solving and employee development inclusive of succession planning.* High level of proficiency in adult education and training, and group presentation* Must be familiar with different approaches to staff and management development using various delivery systems* Skilled in relational databases and ability to use computerized software to support management reporting including word processing, spreadsheets, charts/graphs and presentations* **Managing People** - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes oneself 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.* **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.* **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.* **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. Excellent communication skills, including the ability to speak clearly and persuasively in all situations, listen and gain clarification, respond well to questions and write clearly and informatively* **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.* **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.* **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.* **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 #J-18808-Ljbffr