Process Development Specialist (OSD)

Free Healthcare Option | Bonus Program | 401(k) with Match | College Loan Forgiveness
Core Values: Trustworthy, Relentless, Accountable, Collaborative, Customer-Focused, and Skilled

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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Job Summary:

The Process Development Technical Specialist (Manufacturing Specialist OSD) supports cGMP manufacturing for Oral Solid Dosage. The Process Development Specialist OSD is a key role responsible for overseeing and executing advanced production tasks in the manufacturing of oral solid dosage pharmaceuticals, such as microsphere manufacturing.

The Process Development Specialist is responsible for supporting the optimization, implementation and commercial manufacturing or processes to ensure right-first time to production, efficiency, quality, and cost-effectiveness. This role involves working closely with cross-functional teams, including Formulation Development, Manufacturing, QA & Regulatory, EH&S and Engineering departments to drive continuous improvement and innovation in process development.

This position entails a high level of technical expertise in OSD processes (Drug Substance manufacturing will be considered) and provides a great leadership opportunity in troubleshooting and oversight of GMP manufacturing operations, and responsibility for maintaining quality and compliance with Good Manufacturing Practices (GMP).

The Process Development Technical Specialist performs the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Process Development Technical Specialist employs acceptable techniques while working in manufacturing environments, including PPE gowning.

On-Site Expectations:

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities:

Process Development and Optimization:

• Support launch and optimization of manufacturing processes to enhance efficiency, quality, and productivity.
• Conduct experiments to initiate process improvements and new technologies.
• Evaluate data to identify gaps, troubleshoot issues and recommend corrective action.

Technical Leadership and Collaboration:

• Provide process and equipment expertise and guidance to cross-functional teams.
• Stay current with industry trends, technologies, and best practices to ensure state-of-the-art processes.
• Collaborates with cross-functional teams (e.g., Technical Services Quality Assurance, Engineering) on continuous improvement initiatives to enhance product quality, safety, and efficiency
• Work closely with R&D Formulations, Technical Services Process Engineers to transition new products from development to manufacturing.

Documentation and Compliance:

• Develop and maintain detailed process documentation, including standard operating procedures (SOPs), work instructions, and technical reports.
• Ensure all processes comply with industry regulations, safety standards, and company policies.

Training and Support:

• Oversee and train production staff on new processes and technologies.
• Provide ongoing technical support and troubleshooting assistance to production teams.
• Serves as a subject matter expert (SME) on OSD processes and equipment, providing guidance and training to other manufacturing employees.

Other Expectations:

• Follows applicable SOPs and cGMPs to perform assigned duties and tasks.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Performs applicable manufacturing techniques and technologies per SOPs and cGMPs.
• Performs manufacturing technologies and operation of manufacturing and material handling equipment.
• Documents activities in real time on controlled documentation and legibly, per SOPs and cGMPs.
• Performs in-process testing, weight checks, component counting and basic math calculations.
• Assists with other manufacturing areas as required.
• Performs activities right first time in areas of Solid Oral Dosage: Microencapsulation, Blending, and Bulk Packaging
• Applies job skills, company policies and SOPs to complete a variety of tasks.
• Follows general instructions on routine work, detailed instructions on new projects or assignments.
• Follows all Safety requirements and leads by example a safety-first culture.
• Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.
• Other duties as assigned.

Qualifications:

• Bachelor's degree required, engineering preferred.
• 3+ years of experience in process development or formulation development, preferably in solid oral dosage and/or drug substance manufacturing.
• Proven experience with process optimization and scale-up.
• Good understanding of regulatory requirements and industry standards required.
• Experience with microsphere manufacturing preferred.
• Experience with Lean Manufacturing or other process improvement methodologies preferred.

Knowledge, Skills, and Abilities:

• In-depth knowledge of GMP, FDA regulations, and OSD manufacturing processes.
• Proven ability to operate, troubleshoot, and maintain complex manufacturing equipment.
• Demonstrated leadership skills, with experience training and mentoring team members.
• Strong analytical and problem-solving skills with a focus on detail and accuracy.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.
• Applies job skills, company policies and SOPs to complete a variety of tasks.
• Strong detail orientation and organizational skills required.
• Strong technical and problem-solving and basic trouble-shooting ability required.
• Ability to train others effectively.
• Ability to perform basic math calculations.
• Ability to read and comprehend detailed written instructions required.
• Ability to move materials throughout the facility using appropriate methods and equipment required.
• Proficiency in basic computing skills required.
• Ability to use the appropriate PPE based on product (i.e. PAPR, Supplied Air Respirator).

Physical Demands and Work Environment:

The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 25 pounds, frequently lift and/or move up to 50 pounds, occasionally lift and/or move up to 75 pounds and occasionally lift and/or move over 75 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. The use of tight-fitting respirators limits facial hair for proper protection. Based on product, the use of PAPR or supplied air respirator may be required. Regulations may require employees to participate in routine medical surveillance. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.

About Us:

Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. At Alcami, we are a team of dynamic, agile individuals committed to developing life-saving drugs around the world. A mindset of collaboration, innovation, responsiveness, accountability, and customer focus inspires us to be the most efficient, safe, and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, professional growth, and the opportunity to be part of our skilled team with over 40 years of experience as champions that are dedicated, trustworthy, and relentless to advancing products through every stage of the development cycle. Alcami offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision, and prescription coverage, life, LTD, STD, 401(k) with match and immediate vesting, and tuition reimbursement / student loan forgiveness.

Diversity and Inclusion:

Alcami is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.