Senior Process Engineer – Manufacturing Development and Scale-Up

JOB DESCRIPTION:

Job Title
Senior Process Engineer Manufacturing Development and Scale-Up

Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity working mothers female executives and scientists.

The Opportunity
The position of Senior Process Engineer is within our Infectious Disease business unit located in RMDx in Carlsbad California. This role will lead the transition from smallscale laboratory synthesis to robust reliable and costeffective commercial production. This role is instrumental for building a new strategic capability within the Global Operations network.

This individual will serve as the technical authority for endtoend oligo manufacturing scaleup including solidphase synthesis cleavage/deprotection purification (HPLC and/or ionexchange) desalting formulation and largescale equipment selection. They will partner closely with R&D chemists Operations Quality and Engineering teams to build optimize and validate manufacturing processes within a regulated environment.

What Youll Work On

Manufacturing ScaleUp and Technical Leadership

• Lead development optimization and scaleup of oligonucleotide synthesis processes from milligram/gram lab scale to potentially multikilogram manufacturing scale.
• Translate smallscale synthetic chemistry workflows into highthroughput automated and repeatable manufacturing processes.
• Define technical strategy for purification steps including reversephase ionexchange and/or affinity chromatography.

Process Development and Optimization

• Design experiments (DOE) run scaleup trials and establish critical process parameters (CPPs) and implement manufacturing process controls.
• Develop synthesis and purification workflows optimized for yield purity cycle time and cost.
• Optimize solvent usage resin lifespan column selection and equipment performance.

Technology and Equipment

• Select and commission largescale synthesis platforms chromatography skids preparative HPLC/IEX equipment ultrafiltration/diafiltration systems and associated process automation.
• Partner with engineering to design facility layouts process flow diagrams and equipment specs.

Documentation and Quality

• Author and review process documentation including batch records SOPs validation protocols and change controls.
• Support technology transfer process validation and regulatory submissions.
• Ensure adherence to regulatory requirements and company standards across all activities.

CrossFunctional Leadership

• Act as the manufacturing technical liaison to R&D Quality Regulatory Supply Chain and site leadership teams.
• Mentor chemists and process technicians on synthesis chromatography and process scaleup.

Operational Excellence

• Lead troubleshooting on yield purity impurity profile and equipment performance.
• Collaborate with the Operational Excellence function to implement continuous improvement measures into oligo production processes.

Additional Responsibilities

• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility including product design verification and validation manufacturing and testing activities
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companys policies and practices; build productive internal/external working relationships
• Carries out duties in compliance with established business policies

Required Qualifications

• PhD or equivalent combination of education and experience with a background in Chemical Engineering
• 5 years of related industry oligonucleotides experience preferred 10 years

Preferred Qualifications

• 10 years of industry experience
• Experience in a highly regulated GMP environment
• At least 4 years of experience as the manufacturing technical liaison to R&D Quality Regulatory Supply Chain and site leadership teams.
• At least 4 years of experience as technical authority for endtoend oligo manufacturing scaleup including solidphase synthesis cleavage/deprotection purification (HPLC and/or ionexchange) desalting formulation and largescale equipment selection.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

Connect with us at on LinkedIn at and on Facebook at

The base pay for this position is

In specific locations the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

Senior IC