Responsible for providing technical and strategic stewardship of sterility assurance programs employed at Alcami Corporation. Position is accountable for driving results in a fast-paced environment by leading and coordinating the activities of a pharmaceutical microbiology group in compliance with cGMP and internal SOPs to support manufacturing and laboratory operation. This position is a key team member in driving the sterility assurance agenda and meeting the company’s strategic plan for continued compliance.
- Developing and implementing targeted process improvements, as well as strategic-level transformations, to site sterility assurance programs.
- Leads facility commissioning activities regarding to aseptic processing.
- Understand the scientific principles for manufacturing processes, including the interaction of the chemistry, equipment, 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.
- Manages and prioritizes the functioning of multiple laboratory teams within the microbiology group to provide the timely, compliant and accurate testing of raw materials, in-process samples and finished product, as well as monitoring of environment and critical systems.
- Acts as a subject matter expert in the boarding of the state-of-the-art technologies and instrumentation.
- 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.
- Perform additional duties as required.
Education and Experience
- Bachelors Science in a scientific discipline such as Biochemistry, Biology, Microbiology, Engineering.
- 8 years’ experience in experience in a microbiology lab and aseptic manufacturing, in the pharmaceutical or biotech industry with 3-5 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.
- Ability to analyze complex data and solve problems.
- Technical writing and presentation skills.
- Clear understanding of cGMPs.
- Root Cause Investigation experience.
- 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.
- Highly organized and detail oriented.
- Able to multitask in a fast-paced environment.
- Able to work independently, along with ability to work well within a team.
- Ability to communicate effectively, both orally and in writing.
- Up to 5% travel required.