Responsible for providing technical and scientific support in developing, validating and executing analytical testing at TriPharm Services, Inc. Position will collaborate with cross-functional teams and will work side-by-side with other scientists and professionals to drive the scientific agenda.
- Take a central role in development, validation and testing of small molecules in pharmaceutical products.
- Assist in the boarding of the state-of-the-art technologies and instrumentation.
- Write and review method validation protocols, reports, SOPs, investigations, test methods and specifications.
- Coordinate progress of root cause identification, deviations, change controls, corrective and preventive actions (CAPA).
- Lead commissioning activities and set up of safety programs for the laboratory space.
- Lead the initiative of integration and automation of processes to ensure integrity of laboratory data.
- Act as a Subject Matter Expert (SME) concerning various laboratory software usages (Empower3, ProCal, Master Control, ELN, etc.).
- Lead development of testing templates in Laboratory Information Management System.
- Ensure all equipment is properly calibrated and serviced to support high throughput and full compliance.
- Assist in designing of monitoring and testing programs and strategically evaluates processes for improvements and optimization.
- Identify and lead improvements opportunities to enhance LEAN culture and infrastructure.
- Track and review the project progress to achieve operational goals and metrics.
- Develop team members by adequate training, mentoring and motivation, as well as adherence to quality performance standards.
- Actively participate in cGMP inspections, client visits and regulatory audits.
- Perform additional duties as required.
Education and Experience
- Bachelor's degree in degree in Chemistry or Pharmaceutical Sciences with 6 years related experience, or equivalent education, experience and training; Master's degree with 4 years related experience; Doctorate Degree with 2 years related experience knowledge.
- Proficiency in small molecule testing using HPLC/UPLC, GC, particle size analyzer, dissolution, wet chemistry and other testing methods in a cGMP environment.
- Knowledge of USP, Ph.Eur., FDA, and ICH requirements as they apply to production and testing of drug substances and drug products is a must.
- Experience with inspections/audits by regulatory agencies and clients.
- Ability to find a solution for or to deal proactively with work-related problems; ability to look beyond the standard solutions.
- 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.
- Prior experience with LIMS is preferred.
- Up to 5% travel required.