Manufacturing Specialist

JOB TITLE:  Manufacturing Specialist

EMPLOYER: Evestra, Inc.

DEPARTMENT: Manufacturing

REPORTS TO: Vice President of Manufacturing

EFFECTIVE DATE: 2/12/2024

Our Company:

Evestra, Inc. is an emerging biopharmaceutical company that focuses on developing and commercializing women’s healthcare products. Based in San Antonio, Texas, Evestra’s mission is to improve the health and well-being of women around the world through innovative technologies and products.

General Job Summary:

Evestra, Inc. is seeking to hire a hands-on, results-oriented Manufacturing Specialist, preferentially with experience in cGMP process development and commercial product manufacturing. This individual will join the Manufacturing team at Evestra’s state-of-the-art manufacturing facility in Schertz, Texas. 

DUTIES AND RESPONSIBILITIES:

• Assist in optimizing key process parameters in the unit operations
• Assist in the manufacturing process and operation of pharmaceutical manufacturing and packaging equipment
• Review and follow Standard Operating Procedures (SOPs) and process development/validation protocols
• Provide hands-on support in unit operations involving cryomilling, blending, hot-melt extrusion, cutting, bonding, and packaging
• Ability to work independently in a fast-paced, startup environment
• Collaborates with cross-functional teams on technology transfer and scale-up projects
• Generate and maintain documentation required by projects and operations
• Other duties as assigned by Management

REQUIRED EDUCATIONAL QUALIFICATIONS:

• B.S. in Science or Engineering

DESIRED EXPERIENCE AND SKILL SET:

• 2 years of industry experience in pharmaceutical manufacturing or R&D, biotech, or hot melt extrusion processing, regulated by cGMP standards
• Good troubleshooting skills
• Excellent technical writing and verbal communication skills
• Good math and chemistry skills
• Good problem-solving and analytical skills
• Proficient in Microsoft Word, Excel, and PowerPoint
• Versatility, flexibility, and a willingness to work through changing priorities enthusiastically
• Comfort working in multi-disciplinary teams, learning new skills, and proactively solving problems
• Ability to deal effectively with a diversity of individuals at all organizational levels

COMPETENCIES:

• Analytical--Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
• Problem Solving--Identifies and resolves problems promptly; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem-solving situations; Uses reason even when dealing with emotional topics.
• Interpersonal Skills--Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
• Oral Communication--Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
• Written Communication--Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

• Extended periods of standing, sitting, bending, and kneeling
• Ability to lift and move up to 50 lbs to heights of 10 feet.
• Continually required to utilize hand and finger dexterity
• Continually required to talk or hear
• Required to wear a lab coat, safety glasses, gloves, beard, and hair net
• Frequently utilize visual acuity to operate equipment, read technical information, and/or use a keyboard

The above is intended to describe the general content of and requirements for the performance of this job.  It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements.  Nothing in this job description restricts Management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.