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.
Position Summary
The Senior Scientist - Formulations is accountable for driving results in a fast-paced environment leading pre-formulation laboratory activities for early stage formulation development of liquid drug products for new chemical entities or new dosage forms for existing drugs. The Senior Scientist - Formulations is instrumental in developing solutions, lyophilized injectables, sterile parenterals oral liquids, and liposomal delivery systems. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies including scientific principles, laboratory practices, cGMPs and regulatory requirements for pharmaceuticals and biologicals. Knowledge of early phase drug development and the use of relevant physicochemical properties for solutions development preferred.
Essential Functions
Performs laboratory work related to early stage formulation development of liquid drug products for new chemical entities or new dosage forms for existing drugs.
Develops solutions, lyophilized and injectables, sterile parenterals and oral liquids, lyophilized products and liposomal delivery systems.
Assists in implementing new methods/processes to solve problems.
Writes standard operating procedures (SOPs), test procedures, specifications and summary reports.
Documents results in electronic laboratory notebook.
Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
Operates equipment in accordance with standard procedures.
Writes client communications, deviations, specifications and investigations.
Reviews own work and conducts peer review of department work activity.
Interacts with clients and participate in regulatory agency and/or client audits. Takes lead in client interactions.
Participate in scientific conferences and contribute to scientific journals.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Provides training, and supervision of less experienced scientists.
Education and Experience
Bachelor's degree in Pharmaceutical Sciences, Chemistry or equivalent with 10+ years of experienceorMaster's degree with 5+ years of experience or Ph.D. with 3+ years of experience required.
Experience in development of parenterals and scale up or process development required. Proven ability to run independently
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
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.
Travel Requirements
Up to 5% travel required.
What We Offer You:
Competitive salary with career advancement opportunities
Profit sharing bonus plan
Medical, dental and vision coverage from day one
401(k) with company match
Company paid vacation, holiday and sick-leave
Voluntary benefits including short & long term disability, life, accident, critical illness insurances
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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.
