Posted in Other 30+ days ago.
Type: Full Time
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.
Position Summary
The Scientist - Formulations is accountable for driving results in a fast-paced environment and leading formulation development studies for the design and identification of safe, stable, robust and manufactural pharmaceutical dosage forms. The Scientist - Formulations independently designs, plans, performs, interprets and reports results of scientific experiments for the preparation and timely delivery of drug products (DP), processes and procedures needed for technology transfer and manufacture of the product. 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.
Essential Functions
- Creates formulation development plans and executes well-designed experiments to define the qualitative and quantitative formulation composition.
- Conducts design of experiments (DoE) studies to identify and investigates key and critical quality attributes to confirm formulation robustness as per ICH Q8.
- Writes and executes protocols to prepare formulations for testing and characterization, methods development and technology transfer.
- Records and reports study results in compliance with good scientific policy and procedures.
- Evaluates new scientific technologies/equipment to enhance capability, capacity and efficiency.
- Reports and presents scientific/technical results internally and to external clients.
- Utilizes complex tools/equipment, lab automation tools and specialized facilities.
- Maintains and operates equipment according to safety standards and operating procedures.
- Reviews own work and conducts peer review.
- Participates in scientific conferences and contribute to scientific journals.
- Provides coaching and mentoring to junior colleagues and newcomers.
- Ensures timely completion and compliance with SOPs and all other relevant company training requirements.
Education and Experience
- Bachelor's degree in Pharmaceutical Sciences, Chemistry or equivalent with 5-8 years of experience or Master's degree with 3+ years of experience or Ph.D. with 2+ years of experience required.
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
For Liquid and Sterile Formulation:
- Thorough fundamental knowledge and understanding of solubility and stability theory and practice.
- A solid understanding of drug solubilization and stabilization techniques in liquid dosage forms.
- Hands on expertise in aseptic techniques for liquid formulation, compounding and manufacturing.
- Experience in aseptic filtration, terminal sterilization and lyophilization instrumentation and methods.
- Knowledge of raw material selection strategy and criteria for parenteral and liquid dosage forms.
- Basic understanding of quality attributes and regulatory requirements for parenteral and liquid dosage forms.
- Knowledge of methods for characterization and testing of liquid and parenteral dosage forms.
- Ability to plan and manage multiple tasks for timely achievement of results.
- Ability to efficiently organize work with little or no supervision.
For Oral Solid Dosage Formulation:
- Thorough fundamental knowledge and understanding of solubility and stability theory and practice.
- An understanding of material properties and attributes on solid dosage forms quality and performance.
- Hands on expertise in essential unit operations for solid dosage form manufacture.
- Operational competence in instrumentation and methods for tablet and capsule preparation.
- Knowledge of raw material selection strategy and criteria for solid dosage forms.
- Basic understanding of quality attributes and regulatory requirements for solid dosage forms.
- Knowledge of methods for characterization and testing of solid dosage forms.
- Ability to plan and manage multiple tasks for timely achievement of results.
- Ability to efficiently organize work with little or no supervision.
For Biologics Formulation:
- Thorough fundamental knowledge and understanding of solubility and stability theory and practice.
- A solid understanding of structure and property of biologicals including peptides, protein and monoclonal antibody and single chain fragments in both liquid and lyophilized dosage forms.
- Hands on expertise in biologics special compounding techniques to ensure structural integrity and bioactivity during upstream and downstream compounding (e.g. buffer exchange, mixing, filtration)
- Knowledge of raw material selection strategy and criteria for biologics formulation.
- Basic understanding of quality attributes and regulatory requirements for biologics formulation.
- Knowledge of methods for characterization and testing of biologics formulation.
- Ability to plan and manage multiple tasks for timely achievement of results.
- Ability to efficiently organize work with little or no supervision.
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
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
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