Microbiology Manager
Location: Albuquerque, New Mexico
Description: Oso BioPharmaceuticals Manufacturing, LLC is currently seeking to employ Microbiology Manager right now, this job will be dwelled in New Mexico. More details about this job opportunity please give attention to these descriptions. The Microbiology department is responsible for support of the Manufacturing department and external customers. The two primary functions of the laboratory are envir! onmental monitoring and product testing. Environmental monitoring employs sampling and testing techniques to determine the overall state of control of the manufacturing process. Product testing encompasses assays performed on drug product at various stages to determine product safety and quality.
This position is primarily responsible for activities relating to the daily function of the Microbiology laboratory and strategic planning for the lab and lab staff. The individual is the subject matter expert on contamination control and Microbiological testing of parenteral drug products. The individual is heavily involved in customer and regulatory audits, new client interactions, site metrics meetings, site-wide improvement projects, budgeting and data review and interpretation, including protocols, investigations, and lab documentation. This position is responsible for the entire laboratory team, and is required to perform staff management duties such as reviews, disciplin! ary action, and ensure training is performed. The individual o! perates with very limited supervision and must be able to work both independently and on teams.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Perform reviews; give feedback (e.g. one-on-one meetings), teambuilding and disciplinary action as needed. Provide staffing and lab activity status reports to upper management.
- Attend meetings, including the daily production/lot release meeting, new customer kick-offs, QMR, ERB, MBR, MRB, customer teleconferences, process improvement and customer project teams, raw material release, and staff meetings.
- Perform laboratory audit tours and provide data/discussion to auditors. Primary Microbiology contact for customer and regulatory audits. Perform vendor audits. May participate on internal audit teams.
- Respond to customer/regulatory audit observations and perform/delegate tasks resulting from audit observations
- Prepare presentation! s for training, external teams, and customers.
- Author and review protocols, validation summary reports, change controls, large-scale lab investigations, lab paperwork, stability testing results, media fill batch records, and problem reports. Ability to interpret complex data sets.
- Participate on external teams; attend committees, and conferences (e.g. ASQ). Potential for travel of approximately 2-3 weeks per year.
- Primary contact/key holder for Microbiology lab DEA related issues. Power of Attorney for schedule drugs.
- Able to use creative thinking to solve problems and provide expertise in using risk management and root cause tools for determining CAPA and root cause of issues
- Initiate work orders and manage lab work orders (e.g. periodic testing). Complete work orders in the ERP system.
- Subject matter expert on understanding of regulatory and compendial guidelines for the pharmaceutical industry. Perform compendial revi! ew. Provide input and review in regard to Microbiology for APRs, master! plans, and customer/regulatory inquiries.
- Maintain a detailed and accurate recording of activities and results on paperwork.
- Train upon and understand methods and procedural standard operating procedures. Perform training for lab staff
- Lead department and interdepartmental improvement projects. Perform evaluation of and execution of CAR level equipment purchases
- Determine and maintain laboratory budget and sign off requisitions up to $2500.
- Enter data into relevant data management systems. Perform tracking and trending of data as requested.
- Assist with Director duties such as attending meetings in the absence of the Director
- Other tasks as assigned.
Manages one subordinate supervisor who supervises up to 12 employees in the Microbiology Laboratory. Is responsible for the overall direction, coordination, and evaluation of these units. Also directly supervises four! 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.
Competencies
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; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; 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 tho! se 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 ski! lls.
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 cor! rectly 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.
Judgement - 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 re! alistic 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 unexp! ected 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.
Education and/or Experience - minimum requirements
BS in life sciences; MS (life sciences or business) preferred
Minimum experience required : 6 years laboratory to include 2 yearÂ's management experience
Equivalent combination of education and experience will be considered.
Language Skills
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Mathematical Skills
Ability to work with mathematical concepts such as probability and stati! stical inference, and fundamentals of plane and solid geometry and trig! onometry.. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Computer Skills
To perform this job successfully, an individual should have knowledge of Internet software; Manufacturing software; Spreadsheet software and Word Processing software.
Certificates, Licenses, Registrations
N/A
Other Skills and Abilities
- Ability to manage personnel
- Ability to interact professionally with customers and regulatory agencies
- Advanced knowledge of scientific principles and concepts
- Advanced knowledge of parenteral pharmaceutical guidance and regulations
- Intermedia! te/advanced ability in Word, Excel, Outlook
- Strong mathematical and reasoning ability
- Ability to work independently as well as in a team environment
- Effective communication, verbally and in writing, and ability to interpret and follow instructions
- Ability to work under pressure to meet deadlines while maintaining quality standards
- Attention to detail, organization, and thorough documentation
Pass background check
Pass drug screen / DEA clearance
Pass physical
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 requ! ired to sit. The employee is occasionally required to stand and walk.
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.
The noise level in the work environment is usually moderate.
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If you were eligible to this job, please give us your resume, with salary requirements and a resume to Oso BioPharmaceuticals Manufacturing, LLC.
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This job will be started on: Fri, 10 May 2013 06:48:59 GMT
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