Senior Formulation Scientist, Development

Quva Pharma•Sugar Land, TX

About The Position

Our Senior Formulation Scientist, Development is responsible for managing and supporting formulating new products and any new formulations for existing products for continuous process improvement. This role will collaborate with the development team to support the Pharmacy Services and Technical Services department in developing new and improving existing formulations that will be transferred into commercial products. The Senior Formulation Scientist, Development will also support the Technical Services team as a subject matter expert with addressing important manufacturing issues. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

Requirements

Ph.D. in analytical chemistry or equivalent or Master's degree with extensive experience
7+ years' experience with formulation development in a pharmaceutical environment
10 years advanced R D at scientist/engineer level in pharmaceutical fields
Experience working with controlled substances & sterile injectables
Understanding of cGMP, FDA, ICH principles, guidance and regulation
Experience writing SOPs and critical regulated documents for internal and external business
18+ years of age
Able to successfully complete a drug and background check
Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Nice To Haves

Has a sense of urgency, accountability and resourcefulness (e.g., work in changing environment)
Has good coordinating abilities, attention to detail with positive communication skills
Has excellent organizational skills with ability to manage multiple projects
Is proficient in Microsoft Office

Responsibilities

Innovate and develop new products/patents
Design and develop protocols for new product development and improvement of existing products
Supports administrative activities and meetings for formulation process strategies
Collaborates with Pharmacy Services in developing new product formulations
Collaborates with Technical Services in transferring new products to commercial products
Ensures product deadlines are met and projects are handled in a professional manner
Present ideas for modifying existing procedures and suggest alternative methods to improve results
Perform scientific literature searches and evaluations as required
Collaborating with development in producing for writing new drug formulations
Recommending scientifically sound drug formulations for new products and existing products
Review drug/diluent compatibilities
Ensures pharmaceutical formulations are correct for specific procedures and processes
Supports the Technical Support team with process validations and qualifications
Ensures all proper policies and procedures/work instructions are followed correctly within R D development
Ensures that Master Formularies are up to date and makes any changes pursuant to process improvements and investigations
Ensures all duties and processes are in adherence with ISO standards, USP, and current good compounding practices
Perform change control processes and assist with managing timelines
Writing, maintaining, and improving standard operating procedures related to developed products
Practice and monitors good documentation practices

Benefits

Set, full-time, consistent work schedule
Comprehensive health and wellness benefits including medical, dental and vision
401k retirement program with company match
17 paid days off plus 8 paid holidays per year
Occasional weekend and overtime opportunities with advance notice
National, industry-leading high growth company with future career advancement opportunities

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume