Company Name: 
Societal CDMO
 
Company Description:
Why Join Societal CDMO?  
Mission and Culture:
Each day we Bring Science to Society as we work towards improving the quality of life for patients who benefit from the therapies that we manufacture. We strongly believe that every employee plays an impactful role in accomplishing our mission of improving patients’ lives through client partnerships. Whether you are working hands-on in developing, manufacturing, or, testing the products or if you are utilizing your expertise in any other way, through your work here you will have an opportunity to positively affect countless lives.

We foster a culture that is diverse, inclusive, challenging, and supportive. At Societal, we are committed to continuous improvement both as individuals and as an organization. We encourage our employees to continue their personal and professional development in various ways.
 
Job Title: 
Formulation Development Scientist II
 
Position Summary: 
We are looking for a Product Development II.  In this role, you will support research directed toward the development of new formulations and/or formulation platforms for a significant PD project or a number of small projects with complex features.
 
Primary Responsibilities:

• Lead development activities for client-based projects with supervision, ranging from preclinical studies to NDA submission.
• Execute prototype, scale,e-up, and process transfer activities including manufacture, data evaluation, troubleshooting product/process issues and risk assessments.
• Write, review, and approve cGMP documentation including batch records, protocols, SOPS,
• pharmaceutical development reports, investigation plans, and outcomes for development problems.
• Maintain knowledge of equipment, instrumentation, and procedures related to product development.
• Maintain and expand knowledge of current and new formulation development technologies and
• manufacturing processes.
• Perform literature and patent searches ta o provide a background basis for development plans.
• Attend cGMP training sessions and comply with site-wide and departmental procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security.
• Work in a GMP environment with a variety of compounds (potent, DEA-controlled substances).
• Work closely with Analytical Development, Quality Assurance, and Validation groups.
• May serve as lead for product development activities within cross-departmental project teams.

 
 
Qualifications:

• Candidate must possess one of the following combinations to meet the minimum qualifications:
• Bachelor’s degree in Pharmaceutics, Physical Organic Chemistry, Pharmaceutical Chemistry, Chemical Engineering or similar with 5 years of relevant work experience, or Master’s degree in one of the areas above with 3 years of relevant work experience.
• In-depth knowledge of theory and techniques used in pharmaceutics and physical organic chemistry.
• Familiarity with common pharmaceutical raw materials, their applications, and the principles of formulation development.
• Understanding of statistical design of experiments.
• Strong written and oral communication skills.
• Working knowledge of MS Office (Word, Excel, PowerPoint, Access, and Outlook), Minitab, JMP, or equivalent.

 
 
Benefits:
We offer a competitive total rewards package that includes health benefits, annual performance bonuses, stock options, generous paid time off, holiday shutdowns, parental leave, matching 401k contributions, and much more!
 
Who is Societal:
Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client’s needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry-leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging, and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California, and Gainesville, GA.

If you would like to apply for this position, please visit our website at www.societalcdmo.com and click on the “Careers” section.

New hires will pass a background check, and drug screen as a condition of employment.

We are an EOE dedicated to a diverse workforce and a Drug-Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law.   If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.
 
About The Organization:
Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client’s needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia.