Manager, Quality Control (Microbiology) at Alcami Corporation in Charleston, South Carolina

Posted in Other 9 days ago.





Job Description:

Think Different.  Do Different.  Be Different.


Alcami is a world-class contract development and manufacturing organization (CDMO).  We are a team of dynamic individuals committed to developing life-saving drugs around the world.  A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve.  In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.

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Position Summary


The Manager of Microbiology is accountable for driving results in a fast-paced environment by managing and coordinating the activities of laboratory operations and environmental monitoring. The Manager develops production and resource plans that meet production goals in terms of safety, quality, output and cost. The Manager also ensures proper staff training; conduct key required training. Ensures that deliverables are met or expectations are proactively managed towards alternative solutions. The position works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. The position exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. The Manager engages with business development and contract writing personnel to assist in project definition and costing. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.


 


Essential Functions



  • Developing and implementing targeted process improvements, as well as strategic-level transformations, to site sterility assurance programs.

  • Understand the scientific principles for manufacturing processes, including VHP, steam sterilization and depyrogenation, particle monitoring systems, manufacturing equipment operation as it pertains to environmental risks, utilities monitoring and qualification, aseptic processes and container closure.

  • Use risk-based approaches to evaluate existing manufacturing processes and associated controls with respect to the potential for microbial, endotoxin and particulate contamination and drive improvements across the network.

  • Be an effective source of information and advice on sterility assurance to ensure a robust, effective and compliant sterility assurance and environmental control and monitoring process.

  • Ensures all equipment is properly calibrated and serviced to support high throughput and full compliance.

  • Designs monitoring and testing programs and strategically evaluates processes for improvements and optimization.

  • Writes and reviews risk assessments, test procedures, verification and validation protocols and reports.

  • Actively participates in cGMP inspections, client visits and regulatory audits.

  • Leads investigations and trending of all microbiological test data, inducing formal communication as to the current control of the GMP areas.

  • Establishes and leads corrective actions in response to excursions in controlled environmental areas.

  • Develops team members by adequate training, mentoring and motivation, as well as adherence to quality performance standards.

  • Collaborates with other department to increase synergy and efficiency

  • Acting as a SME on sterility assurance and as a Point-of-Contact for Regulatory Audits.



  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

  • Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.


 


Education and Experience



  • Bachelors Science in a scientific discipline such as Biochemistry, Biology, Microbiology, Engineering.

  • 7+ years’ experience in experience in a microbiology lab and aseptic manufacturing, in the pharmaceutical or biotech industry with 3+ years of that experience in a leadership role.

  • Expert knowledge of USP/EP/FDA requirements, cGMP, aseptic processing, environmental monitoring techniques and microbiological quality control testing (sterility, endotoxin, bioburden, etc).

  • Experience in development, validation and verification of microbiological methods.

  • Experience with inspections/audits by regulatory agencies and clients.

  • Technical writing and presentation skills.

  • Clear understanding of cGMPs.

  • Root Cause Investigation experience.


 


Alcami Non-Negotiables



  • Consistently demonstrates honesty and integrity through personal example.

  • Follows all safety policies and leads by example a safety first culture.

  • Produces high quality work product with a focus on first time right.

  • Complies with the company code of conduct and policies and regulatory standards.


 


Alcami Core Leadership Competencies



  • Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.

  • Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.

  • Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.

  • Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.

  • Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.

  • Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.


 


Functional Competencies



  • Demonstrated knowledge and hands on experience in the area of responsibility.

  • Excellent understanding of the theoretical background/fundamentals of the work.

  • Outstanding capability of client management.

  • Basic understanding of financial performance of the organization.

  • Basic knowledge of hiring and employment practices.

  • Advanced problem solving capabilities.

  • Consistent attention to details.

  • Superior leadership skills.

  • Excellent time management skills.

  • Good organizational skills.

  • Excellent communication and presentation skills.

  • Strong work ethic.

  • Strong team player attitude.

  • Ability to multi-task.

  • Computer proficient.

  • Able to effectively work with employees in other departments and/or groups.

  • Able to effectively train others.


 


Supervisory Responsibilities



  • Directly leads team of approximately 8 - 12 direct reports.

  • Participates in the hiring process of other employees.

  • Makes hiring decisions of other employees.

  • Schedules and reviews the work of other employees.

  • Ensures accuracy and relevance of assigned training curriculum.

  • Drives timely completion of training for employees to meet regulatory requirements.

  • Coaches, mentors and develops other employees.

  • Prepares and delivers performance evaluations of other employees.

  • Makes recommendation of disciplinary actions of other employees.


 


Travel Requirements



  • Up to 10% travel required.


 


 

Diversity and Inclusion:


Alcami values diversity and we are committed to creating an inclusive environment for all employees.   All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

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