Job Description

Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!

Join our mission at Adare!

What can Adare offer you?

Medical/dental/vision/life - low employee premiums 401k with a highly competitive match Generous PTO, including floating holidays Career growth and internal opportunities Tuition reimbursement Relocation assistance Performance-based bonus Employee Recognition Programs

We are seeking to hire a Formulations Technical Specialist to join our Formulations team...

If any of the below describes you, we would love to meet you!

JOB SUMMARY

The Formulations Technical Specialist is responsible for supporting projects by developing and maintaining the necessary documentation and tasks required to fulfil project needs. This person will work alongside project teams to drive activities, accelerate timelines, offer ideas to implement future enhancements/work efficiencies, and provide adequate quality oversight and expertise for the creation and review of internal quality documents.



RESPONSIBILITIES AND LEARNING OPPORTUNITIES

Managing Clinical and Registration Batch Preparation and execution. Responsibilities include: Initiate and retain stability samples per SOP procedures Scheduling clinical batch execution with R&D, Logistics and Operations Facilitate batch record training with Operations and R&D Responsible for the initiation and completion of System Change Controls. Managing actions with multiple departments, reviewing, approving action items until completion and Change Control closure. Serving on the Quality Systems Action Board as the Formulations representative Overseeing the qualification of project raw materials by working with Supply Chain and the Global Quality department with updates on project status and material management from project conception to GMP manufacturing. Contribute to the creation and/or review of project DMF and/or other Regulatory documents as needed Generating and approval of accurate and detailed GMP batch records for clinical trial supplies through Registration manufacturing. Generation and revision of SOP, Work Instruction, and Controlled Forms, to support R&D processes Managing the procurement of raw materials for both formulation development and GMP batch manufacturing following the necessary procedures in order to meet aggressive timelines Detailed management of formulation projects, processes, and procedures to support Formulation Scientists meet aggressive timelines Implement procedural changes to existing internal systems to gain efficiencies to get products to clinical trial status earlier by working with Quality Assurance as well as other departments to implement change Participates in the development and implementation of methods, procedures and regulations necessary for the smooth operation of the business. Other miscellaneous tasks as required

REQUIRED SKILLS AND QUALIFICATIONS

B.S. in Pharmaceutical Sciences, Biochemistry, Chemistry, Chemical Engineering, or a related discipline 3+ years of relevant industry working experience. Strong understanding of GMPs and associated FDA regulations A basic understanding of pharmaceutical formulation development A basic understanding of laboratory analytical equipment

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

PRINCIPALS ONLY

NO AGENCIES OR THIRD PARTIES

Attention Job Seekers and Applicants:

Please be aware of attempted recruiting scams. While Adare does conduct virtual interviews for some positions, we do NOT use Skype or Google Meet. If you are contacted by someone regarding a job opportunity, please be vigilant in reviewing the details of any and all correspondence. Here are some things to look out for: bad grammar; font inconsistencies or formatting irregularity: logos not properly sized, stretched out, blurred; numerous different font styles and sizes within the content of an email or letter; company impersonators (postings that mirror a reputable company, but there's no link to the business) mismatched email or website domains, or there is difficulty with locating an address, business phone number, and/or email address, financial requests: Do not provide payment or account credentials as part of the application process. Legitimate companies should not require transfers, checks, gift cards or the wiring of funds as a condition of the application process. Additionally, equipment purchases: be cautious if a company asks you to purchase your own equipment (computers, iPads, mobile phones) and requests you to mail it to their IT department. Applicant Follow-up Questions: Proceed with caution if you receive an application follow-up request that requires you to click on a link to answer additional questions; especially if the questions request personal information such as a social security number. General anonymity: proceed with caution if you can't quickly verify the identity of the poster.