NCBiotech Jobs Board ● Connecting North Carolina's life science employers and workforce.

Job: Senior Scientist- Formulations (OSD), Alcami, Wilmington, NC

General Information


Job title:
Senior Scientist- Formulations (OSD)
Job location:
Wilmington, NC  28405 United States
Requisition code:
Date posted:
06/22/2021
Compensation:
Job category:
Research and Development
Employment type:
Full time

Job Description


Position Summary

The .  The Sr. 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




  • Develops solids formulations of oral capsules, immediate or modified release tablets.

  • 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 10+ years of experience or Master’s degree with 5+ years of experience or Ph.D. with 3+ 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 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.



Travel Requirements




  • Up to 5% travel required.



 

Job Requirements


(see job description above)
(Job number: 4048650)
Do you know someone who would be interested in this job?   Tell them about it.